Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00567580
Collaborator
National Cancer Institute (NCI) (NIH), Cancer and Leukemia Group B (Other), NRG Oncology (Other)
1,792
460
3
3.9
Study Details
Study Description
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.
PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
Primary
-
To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy.
-
To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy after radical prostatectomy.
Secondary
-
To compare secondary biochemical failure, the development of hormone-refractory disease , distant metastasis, cause-specific mortality, and overall mortality at five years.
-
To compare acute and late morbidity based on Common Toxicity Criteria for Adverse Effects (CTCAE), v. 3.0.
-
To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used.
-
To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms) patterns and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used.
-
To assess the degree, duration, and significant differences of disease-specific health-related quality of life (HRQOL) decrements among treatment arms.
-
To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP.
-
To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells for future translational research analyses.
Tertiary
-
To assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression).
-
To evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies.
-
To assess associations between serum levels of beta-amyloid and measures of cognition and mood and depression.
-
An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system.
OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no), prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs > 1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients are randomized to 1 of 3 treatment arms.
Follow-up occurs 3, 6, and 12 months after the completion of radiation therapy, then every 6 months for 6 years, and then annually thereafter.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1792 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy
Study Start Date
:
Feb 1, 2008
Actual Primary Completion Date
:
Jul 12, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: PBRT Alone Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. |
Radiation: PBRT
1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.
Other Names:
|
| Experimental: PBRT + STAD Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
Radiation: PBRT
1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.
Other Names:
Drug: AA
Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.
Other Names:
Drug: LHRH agonist
Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection.
Other Names:
|
| Experimental: PLNRT + PBRT + STADT Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
Radiation: PBRT
1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.
Other Names:
Radiation: PLNRT
1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.
Other Names:
Drug: AA
Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.
Other Names:
Drug: LHRH agonist
Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Free From Progression (FFP) at 5 Years [From randomization to five years.]
Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen [PSA] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
Secondary Outcome Measures
- Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) [From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.
- Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) [From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
- Percentage of Participants With Local Failure [From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
- Percentage of Participants With Distant Metastasis [From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
- Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality) [From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. [Biochemical progression is indicated by any rise in PSA.] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
- Percentage of Participants Alive (Overall Mortality) [From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.
- Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT) [From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).]
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis.
- Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT) [AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.]
Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring > 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored.
- Comparison of Disease-specific Health Related Quality of Life (HRQOL) Change by the Expanded Prostate Cancer Index Composite (EPIC), Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test A & B, and Controlled Oral Word Association Test (COWAT) [From the 6th week of radiation therapy to 5 years post radiation therapy.]
- Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25) [From the 6th week of radiation therapy to 5 years post radiation therapy.]
- Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY) [From the 6th week of radiation therapy to 5 years post radiation therapy.]
- Evaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D) [From the 6th week of radiation therapy to 5 years post radiation therapy.]
- Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints [Date of randomization to timepoint of the respective primary or secondary endpoint.]
- Assessment of the Relationship(s) Between the American Urological Association Symptom Index (AUA SI) and Urinary Morbidity (Adverse Event Terms: Urinary Frequency/Urgency) Using the CTCAE v. 3.0 Grading System [From the 6th week of radiation therapy to 5 years post radiation therapy.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
• Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic or robotically assisted. There is no time limit for the date of radical prostatectomy.
-
A post-radical prostatectomy entry prostate-specific antigen (PSA) of ≥ 0.1 and < 2.0 ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of registration;
-
One of the following pathologic classifications:
-
T3N0/Nx disease with or without a positive prostatectomy surgical margin; or
-
T2N0/Nx disease with or without a positive prostatectomy surgical margin;
-
Prostatectomy Gleason score of 9 or less;
-
Zubrod Performance Status of 0-1;
-
Age ≥ 18;
-
No distant metastases, based upon the following minimum diagnostic workup:
-
History/physical examination (including digital rectal exam) within 8 weeks (60 days) prior to registration;
-
A computerized tomography (CT) scan of the pelvis (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration;
-
Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
- Adequate bone marrow function, within 90 days prior to registration, defined as follows:
-
Platelets ≥ 100,000 cells/mm^3 based upon compete blood count (CBC);
-
Hemoglobin ≥ 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is recommended).
-
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x the upper limit of normal within 90 days prior to registration;
-
Serum total testosterone must be ≥ 40% of the lower limit of normal (LLN) of the assay used (testosterone ÷ LLN must be ≥ 0.40) within 90 days prior to registration (Note: Patients who have had a unilateral orchiectomy are eligible as long as this requirement is met);
-
Patients must sign a study-specific informed consent prior to study entry.
Exclusion Criteria:
-
A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
-
N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
-
Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration. Note: The use of finasteride or dutasteride (±tamsulosin) for longer periods prior to prostatectomy is acceptable;
-
Androgen deprivation therapy started after prostatectomy and prior to registration (Note: The use of finasteride or dutasteride (±tamsulosin) after prostatectomy is not acceptable - must be stopped within 3 months after prostatectomy. Androgen deprivation therapy must be stopped within 3 months after prostatectomy);
-
Neoadjuvant chemotherapy before or after prostatectomy;
-
Prior chemotherapy for any other disease site if given within 5 years prior to registration;
-
Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
-
Prior pelvic radiotherapy;
-
Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years [for example, carcinoma in situ of the oral cavity is permissible];
-
Severe, active co-morbidity, defined as follows:
-
History of inflammatory bowel disease;
-
History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
-
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
-
Transmural myocardial infarction within the last 6 months;
-
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
-
Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
-
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
-
Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; Note, however, that human immunodeficiency viruses (HIV) testing is not required for entry into this protocol. The need to exclude patients with acquired immunodeficiency syndrome (AIDS) from this protocol is necessary because the treatments involved in this protocol may result in increased toxicity and immunosuppression.
- Prior allergic reaction to the study drug(s) involved in this protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB Comprehensive Cancer Center | Birmingham | Alabama | United States | 35294 |
| 2 | Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks | Alaska | United States | 99701 |
| 3 | Arizona Center for Cancer Care - Peoria | Peoria | Arizona | United States | 85381 |
| 4 | Arizona Oncology Services Foundation | Phoenix | Arizona | United States | 85013 |
| 5 | Arizona Oncology - Tucson | Tucson | Arizona | United States | 85704 |
| 6 | Auburn Radiation Oncology | Auburn | California | United States | 95603 |
| 7 | Peninsula Medical Center | Burlingame | California | United States | 94010 |
| 8 | Radiation Oncology Centers - Cameron Park | Cameron Park | California | United States | 95682 |
| 9 | Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael | California | United States | 95608 |
| 10 | East Bay Radiation Oncology Center | Castro Valley | California | United States | 94546 |
| 11 | Valley Medical Oncology Consultants - Castro Valley | Castro Valley | California | United States | 94546 |
| 12 | Enloe Cancer Center at Enloe Medical Center | Chico | California | United States | 95926 |
| 13 | Valley Medical Oncology | Fremont | California | United States | 94538 |
| 14 | Washington Township Hospital | Fremont | California | United States | 94538 |
| 15 | California Cancer Center - Woodward Park Office | Fresno | California | United States | 93720 |
| 16 | Cancer Care Associates | Fresno | California | United States | 93720 |
| 17 | Rebecca and John Moores UCSD Cancer Center | La Jolla | California | United States | 92093-0658 |
| 18 | Veterans Affairs Medical Center - Long Beach | Long Beach | California | United States | 90822 |
| 19 | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 20 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90089-9181 |
| 21 | Contra Costa Regional Medical Center | Martinez | California | United States | 94553-3156 |
| 22 | Providence Holy Cross Cancer Center | Mission Hills | California | United States | 91346-9600 |
| 23 | Memorial Medical Center | Modesto | California | United States | 95355 |
| 24 | El Camino Hospital Cancer Center | Mountain View | California | United States | 94040 |
| 25 | Sutter Health - Western Division Cancer Research Group | Novato | California | United States | 94945 |
| 26 | Alta Bates Summit Medical Center - Summit Campus | Oakland | California | United States | 94609 |
| 27 | Bay Area Breast Surgeons, Incorporated | Oakland | California | United States | 94609 |
| 28 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609 |
| 29 | Larry G Strieff MD Medical Corporation | Oakland | California | United States | 94609 |
| 30 | Tom K Lee, Incorporated | Oakland | California | United States | 94609 |
| 31 | St. Joseph Hospital Regional Cancer Center - Orange | Orange | California | United States | 92868 |
| 32 | Feather River Hospital Cancer Center | Paradise | California | United States | 95969 |
| 33 | Radiation Oncology Center - Roseville | Roseville | California | United States | 95661 |
| 34 | Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento | California | United States | 95815 |
| 35 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 36 | Mercy General Hospital | Sacramento | California | United States | 95819 |
| 37 | Saint Helena Hospital | Saint Helena | California | United States | 94574 |
| 38 | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
| 39 | California Pacific Medical Center - California Campus | San Francisco | California | United States | 94118 |
| 40 | Doctors Medical Center - San Pablo Campus | San Pablo | California | United States | 94806 |
| 41 | Solano Radiation Oncology Center | Vacaville | California | United States | 95687 |
| 42 | Sutter Solano Medical Center | Vallejo | California | United States | 94589 |
| 43 | Aurora Presbyterian Hospital | Aurora | Colorado | United States | 80012 |
| 44 | Rocky Mountain Cancer Centers - Aurora | Aurora | Colorado | United States | 80012 |
| 45 | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado | United States | 80045 |
| 46 | Boulder Community Hospital | Boulder | Colorado | United States | 80301-9019 |
| 47 | St. Anthony Central Hospital | Denver | Colorado | United States | 80204 |
| 48 | Porter Adventist Hospital | Denver | Colorado | United States | 80210 |
| 49 | Presbyterian - St. Luke's Medical Center | Denver | Colorado | United States | 80218 |
| 50 | St. Joseph Hospital | Denver | Colorado | United States | 80218 |
| 51 | Swedish Medical Center | Englewood | Colorado | United States | 80110 |
| 52 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 53 | Hope Cancer Care Center at Longmont United Hospital | Longmont | Colorado | United States | 80501 |
| 54 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
| 55 | St. Mary - Corwin Regional Medical Center | Pueblo | Colorado | United States | 81004 |
| 56 | North Suburban Medical Center | Thornton | Colorado | United States | 80229 |
| 57 | Exempla Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 58 | Middlesex Hospital Cancer Center | Middletown | Connecticut | United States | 06457 |
| 59 | George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain | Connecticut | United States | 06050 |
| 60 | William W. Backus Hospital | Norwich | Connecticut | United States | 06360 |
| 61 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 62 | Washington Cancer Institute at Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 63 | University of Florida Shands Cancer Center | Gainesville | Florida | United States | 32610-0232 |
| 64 | Integrated Community Oncology Network | Jacksonville Beach | Florida | United States | 32250 |
| 65 | Baptist Cancer Institute - Jacksonville | Jacksonville | Florida | United States | 32207 |
| 66 | Integrated Community Oncology Network at Southside Cancer Center | Jacksonville | Florida | United States | 32207 |
| 67 | Baptist Medical Center South | Jacksonville | Florida | United States | 32258 |
| 68 | Baptist-South Miami Regional Cancer Program | Miami | Florida | United States | 33176 |
| 69 | Integrated Community Oncology Network - Orange Park | Orange Park | Florida | United States | 32073 |
| 70 | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | United States | 32803-1273 |
| 71 | Florida Cancer Center - Palatka | Palatka | Florida | United States | 32177 |
| 72 | Flagler Cancer Center | Saint Augustine | Florida | United States | 32086 |
| 73 | Veterans Affairs Medical Center - Tampa | Tampa | Florida | United States | 33612 |
| 74 | Emory Crawford Long Hospital | Atlanta | Georgia | United States | 30308 |
| 75 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
| 76 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 77 | Northside Hospital Cancer Center | Atlanta | Georgia | United States | 30342-1611 |
| 78 | John B. Amos Cancer Center | Columbus | Georgia | United States | 31904 |
| 79 | Northside Hospital-Forsyth | Cumming | Georgia | United States | 30041 |
| 80 | Piedmont Fayette Hospital | Fayetteville | Georgia | United States | 30214 |
| 81 | Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | United States | 31405 |
| 82 | Kapiolani Medical Center at Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 83 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813 |
| 84 | Queen's Cancer Institute at Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 85 | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii | United States | 96813 |
| 86 | Hawaii Medical Center - East | Honolulu | Hawaii | United States | 96817 |
| 87 | Pacific Cancer Institute - Maui | Wailuku | Hawaii | United States | 96793 |
| 88 | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho | United States | 83706 |
| 89 | Mount Sinai Hospital Medical Center | Chicago | Illinois | United States | 60608 |
| 90 | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | United States | 60611-3013 |
| 91 | University of Chicago Cancer Research Center | Chicago | Illinois | United States | 60637-1470 |
| 92 | Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago | Illinois | United States | 60657 |
| 93 | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | United States | 62526 |
| 94 | Leonard C. Ferguson Cancer Center | Freeport | Illinois | United States | 61032 |
| 95 | Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey | Illinois | United States | 60426 |
| 96 | Veterans Affairs Medical Center - Hines | Hines | Illinois | United States | 60141 |
| 97 | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 98 | Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | Moline | Illinois | United States | 61265 |
| 99 | Cancer Institute at St. John's Hospital | Springfield | Illinois | United States | 62702 |
| 100 | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | United States | 62781-0001 |
| 101 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 102 | Radiation Oncology Associates Southwest | Fort Wayne | Indiana | United States | 46804 |
| 103 | Parkview Regional Cancer Center at Parkview Health | Fort Wayne | Indiana | United States | 46805 |
| 104 | Center for Cancer Care at Goshen General Hospital | Goshen | Indiana | United States | 46526 |
| 105 | Howard Community Hospital | Kokomo | Indiana | United States | 46904 |
| 106 | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | United States | 46350 |
| 107 | Saint Joseph Regional Medical Center | Mishawaka | Indiana | United States | 46545-1470 |
| 108 | CCOP - Northern Indiana CR Consortium | South Bend | Indiana | United States | 46601 |
| 109 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 110 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
| 111 | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 112 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
| 113 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
| 114 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 115 | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
| 116 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
| 117 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51102 |
| 118 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
| 119 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
| 120 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
| 121 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 122 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
| 123 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67208 |
| 124 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 125 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
| 126 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
| 127 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 128 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
| 129 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
| 130 | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | United States | 40536-0093 |
| 131 | Norton Suburban Hospital | Louisville | Kentucky | United States | 40207 |
| 132 | Tulane Cancer Center Office of Clinical Research | Alexandria | Louisiana | United States | 71315-3198 |
| 133 | Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge | Louisiana | United States | 70809 |
| 134 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
| 135 | Medical Center of Louisiana - New Orleans | New Orleans | Louisiana | United States | 70112 |
| 136 | CCOP - Ochsner | New Orleans | Louisiana | United States | 70121 |
| 137 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 138 | Greater Baltimore Medical Center Cancer Center | Baltimore | Maryland | United States | 21204 |
| 139 | St. Agnes Hospital Cancer Center | Baltimore | Maryland | United States | 21229 |
| 140 | Central Maryland Oncology Center | Columbia | Maryland | United States | 21044 |
| 141 | Tate Cancer Center at Baltimore Washington Medical Center | Glen Burnie | Maryland | United States | 21061 |
| 142 | Holy Cross Hospital | Silver Spring | Maryland | United States | 20910 |
| 143 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 144 | Dana-Farber/Brigham and Women's Cancer Center | Boston | Massachusetts | United States | 02115 |
| 145 | Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 146 | Boston University Cancer Research Center | Boston | Massachusetts | United States | 02118 |
| 147 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 148 | Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River | Massachusetts | United States | 02721 |
| 149 | Cape Cod Hospital | Hyannis | Massachusetts | United States | 02601 |
| 150 | Lowell General Hospital | Lowell | Massachusetts | United States | 01854 |
| 151 | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | United States | 49221 |
| 152 | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | United States | 48106-0995 |
| 153 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
| 154 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0942 |
| 155 | Henry Ford Macomb Hospital | Clinton Township | Michigan | United States | 48038 |
| 156 | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | United States | 48123-2500 |
| 157 | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 158 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 159 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 160 | McLaren Cancer Institute | Flint | Michigan | United States | 48532 |
| 161 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
| 162 | Foote Memorial Hospital | Jackson | Michigan | United States | 49201 |
| 163 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49001 |
| 164 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007-3731 |
| 165 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
| 166 | Sparrow Regional Cancer Center | Lansing | Michigan | United States | 48912-1811 |
| 167 | St. Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 168 | St. Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341-2985 |
| 169 | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | United States | 48060 |
| 170 | William Beaumont Hospital - Royal Oak Campus | Royal Oak | Michigan | United States | 48073 |
| 171 | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | United States | 48601 |
| 172 | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | United States | 49085 |
| 173 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
| 174 | MeritCare Bemidji | Bemidji | Minnesota | United States | 56601 |
| 175 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 176 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 177 | St. Luke's Hospital Cancer Care Center | Duluth | Minnesota | United States | 55805 |
| 178 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 179 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 180 | Immanuel St. Joseph's | Mankato | Minnesota | United States | 56002 |
| 181 | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | United States | 55109 |
| 182 | Minnesota Oncology - Maplewood | Maplewood | Minnesota | United States | 55109 |
| 183 | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 184 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
| 185 | Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | United States | 55422-2900 |
| 186 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 187 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
| 188 | Park Nicollet Cancer Center | Saint Louis Park | Minnesota | United States | 55416 |
| 189 | Regions Hospital Cancer Care Center | Saint Paul | Minnesota | United States | 55101 |
| 190 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 191 | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | United States | 55379 |
| 192 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 193 | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
| 194 | Minnesota Oncology - Woodbury | Woodbury | Minnesota | United States | 55125 |
| 195 | Regional Cancer Center at Singing River Hospital | Pascagoula | Mississippi | United States | 39581 |
| 196 | Cancer Institute of Cape Girardeau, LLC | Cape Girardeau | Missouri | United States | 63703 |
| 197 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
| 198 | Barnes-Jewish West County Hospital | Saint Louis | Missouri | United States | 63141 |
| 199 | Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters | Missouri | United States | 63376 |
| 200 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 201 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
| 202 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
| 203 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
| 204 | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | United States | 59405 |
| 205 | Cancer Resource Center - Lincoln | Lincoln | Nebraska | United States | 68510 |
| 206 | Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center | Lincoln | Nebraska | United States | 68510 |
| 207 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
| 208 | Methodist Estabrook Cancer Center | Omaha | Nebraska | United States | 68114 |
| 209 | Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
| 210 | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
| 211 | Lakeside Hospital | Omaha | Nebraska | United States | 68130 |
| 212 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131-2197 |
| 213 | Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 214 | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | United States | 89106 |
| 215 | Center for Cancer Care at Exeter Hospital | Exeter | New Hampshire | United States | 03833 |
| 216 | Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene | New Hampshire | United States | 03431 |
| 217 | Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756-0002 |
| 218 | Memorial Sloan-Kettering Cancer Center - Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 219 | AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus | Galloway | New Jersey | United States | 08240 |
| 220 | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | United States | 08053 |
| 221 | Saint Peter's University Hospital | New Brunswick | New Jersey | United States | 08901 |
| 222 | Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08903 |
| 223 | Capital Health Regional Cancer Center | Pennington | New Jersey | United States | 08534 |
| 224 | Valley Hospital - Ridgewood | Ridgewood | New Jersey | United States | 07450 |
| 225 | Somerset Medical Center | Somerville | New Jersey | United States | 08876 |
| 226 | Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta | New Jersey | United States | 07871 |
| 227 | Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland | New Jersey | United States | 08360 |
| 228 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 229 | Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees | New Jersey | United States | 08043 |
| 230 | New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87109 |
| 231 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87131-5636 |
| 232 | University of New Mexico Cancer Center - South | Las Cruces | New Mexico | United States | 88011 |
| 233 | New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany | New York | United States | 12206 |
| 234 | New York Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 235 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263-0001 |
| 236 | Sands Cancer Center | Canandaigua | New York | United States | 14424 |
| 237 | Memorial Sloan-Kettering Cancer Center | Commack | New York | United States | 11725 |
| 238 | Stich Radiation Center at NewYork-Presbyterian Hospital/Weill Cornell Medical Center | New York | New York | United States | 10021 |
| 239 | St. Luke's - Roosevelt Hospital Center - St.Luke's Division | New York | New York | United States | 10025 |
| 240 | Dyson Center for Cancer Care at Vassar Brothers Medical Center | Poughkeepsie | New York | United States | 12601-3990 |
| 241 | Hudson Valley Oncology Associates | Poughkeepsie | New York | United States | 12601 |
| 242 | Highland Hospital of Rochester | Rochester | New York | United States | 14620 |
| 243 | Lipson Cancer and Blood Center at Rochester General Hospital | Rochester | New York | United States | 14621 |
| 244 | University Radiation Oncology at Parkridge Hospital | Rochester | New York | United States | 14626 |
| 245 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 246 | Memorial Sloan-Kettering Cancer Center - Rockville Centre | Rockville Centre | New York | United States | 11570 |
| 247 | Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | United States | 10591 |
| 248 | Randolph Hospital | Asheboro | North Carolina | United States | 27203-5400 |
| 249 | Mission Hospitals - Memorial Campus | Asheville | North Carolina | United States | 28801 |
| 250 | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 27599-7295 |
| 251 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 252 | Moses Cone Regional Cancer Center at Wesley Long Community Hospital | Greensboro | North Carolina | United States | 27403-1198 |
| 253 | Coleman Radiation Oncology Center at Carter General Hospital | Morehead City | North Carolina | United States | 28557 |
| 254 | CarolinaEast Cancer Care | New Bern | North Carolina | United States | 28560 |
| 255 | FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst | North Carolina | United States | 28374 |
| 256 | Rex Cancer Center at Rex Hospital | Raleigh | North Carolina | United States | 27607 |
| 257 | Annie Penn Cancer Center | Reidsville | North Carolina | United States | 27320 |
| 258 | South Atlantic Radiation Oncology, LLC | Supply | North Carolina | United States | 28462 |
| 259 | Coastal Carolina Radiation Oncology Center | Wilmington | North Carolina | United States | 28401 |
| 260 | Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington | North Carolina | United States | 28401 |
| 261 | MeritCare Broadway | Fargo | North Dakota | United States | 58102 |
| 262 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
| 263 | Roger Maris Cancer Center at MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
| 264 | Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | United States | 58201 |
| 265 | McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | United States | 44307 |
| 266 | Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | United States | 44309-2090 |
| 267 | Barberton Citizens Hospital | Barberton | Ohio | United States | 44203 |
| 268 | Aultman Cancer Center at Aultman Hospital | Canton | Ohio | United States | 44710-1799 |
| 269 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 270 | Case Comprehensive Cancer Center | Cleveland | Ohio | United States | 44106-5065 |
| 271 | Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 272 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 273 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
| 274 | Riverside Methodist Hospital Cancer Care | Columbus | Ohio | United States | 43214-3998 |
| 275 | CCOP - Columbus | Columbus | Ohio | United States | 43215 |
| 276 | Grant Medical Center Cancer Care | Columbus | Ohio | United States | 43215 |
| 277 | Mount Carmel Health - West Hospital | Columbus | Ohio | United States | 43222 |
| 278 | Doctors Hospital at Ohio Health | Columbus | Ohio | United States | 43228 |
| 279 | Grady Memorial Hospital | Delaware | Ohio | United States | 43015 |
| 280 | Community Cancer Center | Elyria | Ohio | United States | 44035 |
| 281 | Hematology Oncology Center | Elyria | Ohio | United States | 44035 |
| 282 | Cleveland Clinic Cancer Center | Independence | Ohio | United States | 44131 |
| 283 | Lima Memorial Hospital | Lima | Ohio | United States | 45804 |
| 284 | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 285 | Northwest Ohio Oncology Center | Maumee | Ohio | United States | 43537-1839 |
| 286 | Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights | Ohio | United States | 44124 |
| 287 | Lake/University Ireland Cancer Center | Mentor | Ohio | United States | 44060 |
| 288 | Southwest General Health Center | Middleburg Heights | Ohio | United States | 44130 |
| 289 | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
| 290 | UHHS Chagrin Highlands Medical Center | Orange Village | Ohio | United States | 44122 |
| 291 | St. Charles Mercy Hospital | Oregon | Ohio | United States | 43616 |
| 292 | Parma Community General Hospital | Parma | Ohio | United States | 44129 |
| 293 | Southern Ohio Medical Center Cancer Center | Portsmouth | Ohio | United States | 45662 |
| 294 | Cancer Care Center, Incorporated | Salem | Ohio | United States | 44460 |
| 295 | North Coast Cancer Care, Incorporated | Sandusky | Ohio | United States | 44870 |
| 296 | Community Hospital of Springfield and Clark County | Springfield | Ohio | United States | 45505 |
| 297 | Tony Teramana Cancer Center | Steubenville | Ohio | United States | 43952 |
| 298 | Cleveland Clinic Foundation - Strongsville | Strongsville | Ohio | United States | 44136 |
| 299 | Flower Hospital Cancer Center | Sylvania | Ohio | United States | 43560 |
| 300 | Mercy Hospital of Tiffin | Tiffin | Ohio | United States | 44883 |
| 301 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 302 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
| 303 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
| 304 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43617 |
| 305 | St. Anne Mercy Hospital | Toledo | Ohio | United States | 43623 |
| 306 | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | United States | 43623 |
| 307 | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | United States | 43081 |
| 308 | UHHS Westlake Medical Center | Westlake | Ohio | United States | 44145 |
| 309 | Cancer Treatment Center | Wooster | Ohio | United States | 44691 |
| 310 | Cleveland Clinic - Wooster | Wooster | Ohio | United States | 44691 |
| 311 | Genesis - Good Samaritan Hospital | Zanesville | Ohio | United States | 43701 |
| 312 | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma | United States | 73104 |
| 313 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
| 314 | Willamette Valley Cancer Center - Eugene | Eugene | Oregon | United States | 97401 |
| 315 | Three Rivers Community Hospital | Grants Pass | Oregon | United States | 97527 |
| 316 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
| 317 | Dubs Cancer Center at Rogue Valley Medical Center | Medford | Oregon | United States | 97504 |
| 318 | Providence Cancer Center at PMCC | Medford | Oregon | United States | 97504 |
| 319 | Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland | Oregon | United States | 97210 |
| 320 | Salem Hospital Regional Cancer Care Services | Salem | Oregon | United States | 97309-5014 |
| 321 | Legacy Meridian Park Hospital | Tualatin | Oregon | United States | 97062 |
| 322 | Rosenfeld Cancer Center at Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 323 | UPMC Cancer Center at Beaver Medical Center | Beaver | Pennsylvania | United States | 15009 |
| 324 | St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania | United States | 18015 |
| 325 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
| 326 | UPMC Cancer Center at Jefferson Regional Medical Center | Clairton | Pennsylvania | United States | 15025 |
| 327 | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | United States | 17822-0001 |
| 328 | Northeast Radiation Oncology Center | Dunmore | Pennsylvania | United States | 18512 |
| 329 | Adams Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 330 | UPMC Cancer Center - Arnold Palmer Pavilion | Greensburg | Pennsylvania | United States | 15601 |
| 331 | Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania | United States | 17033-0850 |
| 332 | UPMC Cancer Center at the John P. Murtha Pavilion | Johnstown | Pennsylvania | United States | 15901 |
| 333 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17604 |
| 334 | St. Mary Regional Cancer Center | Langhorne | Pennsylvania | United States | 19047 |
| 335 | UPMC Cancer Center at UPMC McKeesport | McKeesport | Pennsylvania | United States | 15132 |
| 336 | Upper Delaware Valley Cancer Center | Milford | Pennsylvania | United States | 18337 |
| 337 | Intercommunity Cancer Center | Monroeville | Pennsylvania | United States | 15146 |
| 338 | UPMC - Moon | Moon | Pennsylvania | United States | 15108 |
| 339 | Alle-Kiski Medical Center | Natrona Heights | Pennsylvania | United States | 15065 |
| 340 | UPMC Cancer Center - Natrona Heights | Natrona Heights | Pennsylvania | United States | 15065 |
| 341 | Jameson Memorial Hospital - North Campus | New Castle | Pennsylvania | United States | 16105 |
| 342 | Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301-1792 |
| 343 | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107-5541 |
| 344 | Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | United States | 19111-2497 |
| 345 | Albert Einstein Cancer Center | Philadelphia | Pennsylvania | United States | 19141 |
| 346 | Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
| 347 | UPMC - Shadyside | Pittsburgh | Pennsylvania | United States | 15213-2582 |
| 348 | UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 349 | UPMC Cancer Center at UPMC Presbyterian | Pittsburgh | Pennsylvania | United States | 15213 |
| 350 | UPMC Cancer Center at UPMC St. Margaret | Pittsburgh | Pennsylvania | United States | 15215 |
| 351 | UPMC Cancer Center at UPMC Passavant | Pittsburgh | Pennsylvania | United States | 15237 |
| 352 | UPMC Cancer Center - Upper St. Clair | Pittsburgh | Pennsylvania | United States | 15243 |
| 353 | St. Joseph Medical Center | Reading | Pennsylvania | United States | 19605 |
| 354 | McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | United States | 19612-6052 |
| 355 | Washington Hospital Cancer Center | Washington | Pennsylvania | United States | 15301 |
| 356 | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 357 | CCOP - Main Line Health | Wynnewood | Pennsylvania | United States | 19096 |
| 358 | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
| 359 | York Cancer Center at Apple Hill Medical Center | York | Pennsylvania | United States | 17405 |
| 360 | AnMed Cancer Center | Anderson | South Carolina | United States | 29621 |
| 361 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 362 | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina | United States | 29605 |
| 363 | Cancer Centers of the Carolinas - Grove Commons | Greenville | South Carolina | United States | 29605 |
| 364 | Cancer Centers of the Carolinas - Eastside | Greenville | South Carolina | United States | 29615 |
| 365 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
| 366 | Cancer Centers of the Carolinas - Greer Medical Oncology | Greer | South Carolina | United States | 29650 |
| 367 | Cancer Centers of the Carolinas - Greer Radiation Oncology | Greer | South Carolina | United States | 29650 |
| 368 | Hilton Head Radiation Oncology Center | Hilton Head Island | South Carolina | United States | 29926 |
| 369 | Cancer Centers of the Carolinas - Seneca | Seneca | South Carolina | United States | 29672 |
| 370 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
| 371 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 372 | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina | United States | 29307 |
| 373 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 374 | West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson | Tennessee | United States | 38301 |
| 375 | Texas Oncology, PA at Harris Center HEB | Bedford | Texas | United States | 76022 |
| 376 | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas | United States | 75390 |
| 377 | Texas Oncology, PA at Texas Cancer Center - Denton South | Denton | Texas | United States | 76210 |
| 378 | Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth | Texas | United States | 76104 |
| 379 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0361 |
| 380 | Memorial Hermann Hospital - Memorial City | Houston | Texas | United States | 77024 |
| 381 | Texas Oncology, PA at Lake Vista Cancer Center | Lewisville | Texas | United States | 75067 |
| 382 | Longview Cancer Center | Longview | Texas | United States | 75601 |
| 383 | Cancer Care Centers of South Texas - Northeast | San Antonio | Texas | United States | 78217 |
| 384 | Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman | Texas | United States | 75090 |
| 385 | Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land | Texas | United States | 77479 |
| 386 | Tyler Cancer Center | Tyler | Texas | United States | 75702 |
| 387 | Texas Oncology, PA - Wichita Falls | Wichita Falls | Texas | United States | 76310 |
| 388 | Sandra L. Maxwell Cancer Center | Cedar City | Utah | United States | 84720 |
| 389 | Logan Regional Hospital | Logan | Utah | United States | 84321 |
| 390 | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | United States | 84157 |
| 391 | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 392 | Utah Valley Regional Medical Center - Provo | Provo | Utah | United States | 84604 |
| 393 | Dixie Regional Medical Center - East Campus | Saint George | Utah | United States | 84770 |
| 394 | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | United States | 84106 |
| 395 | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | United States | 84112 |
| 396 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 397 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 398 | Norris Cotton Cancer Center - North | Saint Johnsbury | Vermont | United States | 05819 |
| 399 | INOVA Alexandria Hospital | Alexandria | Virginia | United States | 22304 |
| 400 | Martha Jefferson Hospital Cancer Care Center | Charlottesville | Virginia | United States | 22901 |
| 401 | Danville Regional Medical Center | Danville | Virginia | United States | 24541 |
| 402 | Sentara Cancer Institute at Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 403 | Naval Medical Center - Portsmouth | Portsmouth | Virginia | United States | 23708-2197 |
| 404 | Veterans Affairs Medical Center - Richmond | Richmond | Virginia | United States | 23249 |
| 405 | Coastal Cancer Center at Sentara Virginia Beach General Hospital | Virginia Beach | Virginia | United States | 23454 |
| 406 | St. Joseph Cancer Center | Bellingham | Washington | United States | 98225 |
| 407 | St. Francis Hospital | Federal Way | Washington | United States | 98003 |
| 408 | Good Samaritan Cancer Center | Puyallup | Washington | United States | 98372 |
| 409 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
| 410 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 411 | Cancer Care Northwest - Spokane South | Spokane | Washington | United States | 99202 |
| 412 | Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington | United States | 98405-3004 |
| 413 | CCOP - Northwest | Tacoma | Washington | United States | 98405 |
| 414 | MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 415 | Legacy Salmon Creek Medical Center | Vancouver | Washington | United States | 98686 |
| 416 | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 417 | West Virginia University Health Sciences Center - Charleston | Charleston | West Virginia | United States | 25304 |
| 418 | Langlade Memorial Hospital | Antigo | Wisconsin | United States | 54409 |
| 419 | Fox Valley Hematology and Oncology - East Grant Street | Appleton | Wisconsin | United States | 54911-3496 |
| 420 | Theda Care Cancer Institute | Appleton | Wisconsin | United States | 54911 |
| 421 | Beloit Memorial Hospital | Beloit | Wisconsin | United States | 53511 |
| 422 | Central Wisconsin Cancer Program at Agnesian HealthCare | Fond Du Lac | Wisconsin | United States | 54935 |
| 423 | Bellin Memorial Hospital | Green Bay | Wisconsin | United States | 54301 |
| 424 | St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | United States | 54307-3508 |
| 425 | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | United States | 54601 |
| 426 | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | United States | 54601 |
| 427 | University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | United States | 53792-6164 |
| 428 | Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | United States | 54143 |
| 429 | Community Memorial Hospital Cancer Care Center | Menomonee Falls | Wisconsin | United States | 53051 |
| 430 | Columbia Saint Mary's Hospital - Ozaukee | Mequon | Wisconsin | United States | 53097 |
| 431 | Columbia-Saint Mary's Water Tower Medical Commons | Milwaukee | Wisconsin | United States | 53211 |
| 432 | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 433 | Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | United States | 53226 |
| 434 | Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | United States | 53295 |
| 435 | D.N. Greenwald Center | Mukwonago | Wisconsin | United States | 53149 |
| 436 | Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
| 437 | All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin | United States | 53405 |
| 438 | Door County Cancer Center at Door County Memorial Hospital | Sturgeon Bay | Wisconsin | United States | 54235-1495 |
| 439 | Aurora Medical Center | Summit | Wisconsin | United States | 53066 |
| 440 | Waukesha Memorial Hospital Regional Cancer Center | Waukesha | Wisconsin | United States | 53188 |
| 441 | University of Wisconcin Cancer Center at Aspirus Wausau Hospital | Wausau | Wisconsin | United States | 54401 |
| 442 | West Allis Memorial Hospital | West Allis | Wisconsin | United States | 53227 |
| 443 | Riverview UW Cancer Center at Riverview Hospital | Wisconsin Rapids | Wisconsin | United States | 54494 |
| 444 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
| 445 | Tom Baker Cancer Centre - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
| 446 | Cross Cancer Institute at University of Alberta | Edmonton | Alberta | Canada | T6G 1Z2 |
| 447 | Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 4L2 |
| 448 | Doctor H. Bliss Murphy Cancer Centre | Saint John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 449 | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 450 | London Regional Cancer Program at London Health Sciences Centre | London | Ontario | Canada | N6A 4L6 |
| 451 | Cancer Care Program at Thunder Bay Regional Health Sciences | Thunder Bay | Ontario | Canada | P7B 6V4 |
| 452 | Maisonneuve-Rosemont Hospital | Montreal | Quebec | Canada | H1T 2M4 |
| 453 | Hopital Notre-Dame du CHUM | Montreal | Quebec | Canada | H2L 4M1 |
| 454 | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec | Canada | G1R 2J6 |
| 455 | CHUS-Hopital Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 456 | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan | Canada | S4T 7T1 |
| 457 | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 458 | Pamela Youde Nethersole Eastern Hospital | Hong Kong | China | ||
| 459 | Rabin Medical Center - Beilinson Campus | Petach Tikva | Israel | 49100 | |
| 460 | Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel | 64239 |
Sponsors and Collaborators
- Radiation Therapy Oncology Group
- National Cancer Institute (NCI)
- Cancer and Leukemia Group B
- NRG Oncology
Investigators
- Principal Investigator: Alan Pollack, MD, PhD, University of Miami
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00567580
Other Study ID Numbers:
- RTOG-0534
- CDR0000577574
- NCI-2009-00733
- NCT01312974
First Posted:
Dec 5, 2007
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Keywords provided by Radiation Therapy Oncology Group
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Period Title: Overall Study | |||
| STARTED | 592 | 602 | 598 |
| Eligible | 564 | 578 | 574 |
| Eligible, Started Study Treatment, and Have Adverse Event Data | 547 | 563 | 563 |
| COMPLETED | 564 | 578 | 574 |
| NOT COMPLETED | 28 | 24 | 24 |
Baseline Characteristics
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD | Total |
|---|---|---|---|---|
| Arm/Group Description | Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | Total of all reporting groups |
| Overall Participants | 564 | 578 | 574 | 1716 |
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
64
|
64
|
64
|
64
|
| Age, Customized (Count of Participants) | ||||
| <=49 |
19
3.4%
|
15
2.6%
|
8
1.4%
|
42
2.4%
|
| 50-59 |
118
20.9%
|
137
23.7%
|
138
24%
|
393
22.9%
|
| 60-69 |
307
54.4%
|
299
51.7%
|
307
53.5%
|
913
53.2%
|
| >=70 |
120
21.3%
|
127
22%
|
121
21.1%
|
368
21.4%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
564
100%
|
578
100%
|
574
100%
|
1716
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
21
3.7%
|
23
4%
|
30
5.2%
|
74
4.3%
|
| Not Hispanic or Latino |
511
90.6%
|
527
91.2%
|
517
90.1%
|
1555
90.6%
|
| Unknown or Not Reported |
32
5.7%
|
28
4.8%
|
27
4.7%
|
87
5.1%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
5
0.9%
|
5
0.3%
|
| Asian |
3
0.5%
|
6
1%
|
8
1.4%
|
17
1%
|
| Native Hawaiian or Other Pacific Islander |
1
0.2%
|
4
0.7%
|
0
0%
|
5
0.3%
|
| Black or African American |
74
13.1%
|
69
11.9%
|
77
13.4%
|
220
12.8%
|
| White |
464
82.3%
|
482
83.4%
|
474
82.6%
|
1420
82.8%
|
| More than one race |
3
0.5%
|
0
0%
|
0
0%
|
3
0.2%
|
| Unknown or Not Reported |
19
3.4%
|
17
2.9%
|
10
1.7%
|
46
2.7%
|
| Zubrod Performance Status (Count of Participants) | ||||
| 0 |
522
92.6%
|
539
93.3%
|
540
94.1%
|
1601
93.3%
|
| 1 |
42
7.4%
|
39
6.7%
|
34
5.9%
|
115
6.7%
|
| Pathologic Seminal Vesicle Involvement (Count of Participants) | ||||
| No |
482
85.5%
|
494
85.5%
|
488
85%
|
1464
85.3%
|
| Yes |
82
14.5%
|
84
14.5%
|
86
15%
|
252
14.7%
|
| Prostatectomy Tumor Stage (Count of Participants) | ||||
| pT2 |
292
51.8%
|
317
54.8%
|
304
53%
|
913
53.2%
|
| pT3 Extraprostatic extension NOS |
13
2.3%
|
15
2.6%
|
18
3.1%
|
46
2.7%
|
| pT3a Extraprostatic extension |
177
31.4%
|
162
28%
|
166
28.9%
|
505
29.4%
|
| pT3b Seminal vesicle invasion |
82
14.5%
|
84
14.5%
|
86
15%
|
252
14.7%
|
| Gleason Score (Count of Participants) | ||||
| 4 |
0
0%
|
1
0.2%
|
1
0.2%
|
2
0.1%
|
| 5 |
3
0.5%
|
1
0.2%
|
5
0.9%
|
9
0.5%
|
| 6 |
80
14.2%
|
85
14.7%
|
89
15.5%
|
254
14.8%
|
| 7: 3+4 |
226
40.1%
|
240
41.5%
|
221
38.5%
|
687
40%
|
| 7:4+3 |
153
27.1%
|
148
25.6%
|
156
27.2%
|
457
26.6%
|
| 7: primary/secondary not indicated |
9
1.6%
|
5
0.9%
|
3
0.5%
|
17
1%
|
| 8 |
57
10.1%
|
60
10.4%
|
57
9.9%
|
174
10.1%
|
| 9 |
36
6.4%
|
38
6.6%
|
42
7.3%
|
116
6.8%
|
| Prostatectomy Margins (Count of Participants) | ||||
| Positive |
288
51.1%
|
289
50%
|
284
49.5%
|
861
50.2%
|
| Negative |
267
47.3%
|
284
49.1%
|
287
50%
|
838
48.8%
|
| Unknown |
9
1.6%
|
5
0.9%
|
3
0.5%
|
17
1%
|
| Pelvic Lymphadenectomy (Count of Participants) | ||||
| No |
189
33.5%
|
207
35.8%
|
209
36.4%
|
605
35.3%
|
| Yes |
375
66.5%
|
371
64.2%
|
365
63.6%
|
1111
64.7%
|
| Number of Lymph Nodes Examined (lymph nodes) [Median (Full Range) ] | ||||
| Median (Full Range) [lymph nodes] |
5
|
6
|
5
|
6
|
| Pre-RT Entry PSA (ng/ml) [Median (Full Range) ] | ||||
| Median (Full Range) [ng/ml] |
0.32
|
0.40
|
0.32
|
0.35
|
| Pre-RT Entry PSA (Count of Participants) | ||||
| >= 0.1 and <= 0.2 ng/ml |
155
27.5%
|
126
21.8%
|
154
26.8%
|
435
25.3%
|
| > 0.2 and <= 0.5 ng/ml |
247
43.8%
|
256
44.3%
|
247
43%
|
750
43.7%
|
| > 0.5 and <= 1.0 ng/ml |
105
18.6%
|
130
22.5%
|
114
19.9%
|
349
20.3%
|
| > 1.0 and < 2.0 ng/ml |
57
10.1%
|
66
11.4%
|
59
10.3%
|
182
10.6%
|
Outcome Measures
| Title | Percentage of Participants Free From Progression (FFP) at 5 Years |
|---|---|
| Description | Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen [PSA] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section. |
| Time Frame | From randomization to five years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
70.3
12.5%
|
81.3
14.1%
|
87.4
15.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.001 | |
| Method | Z test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | Z-test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | Alternative hypotheses: 10% improvement in 5-year FFP in Arm 2 and 20% improvement in Arm 3, both relative to Arm 1, which has an assumed 5-year FFP of 70%. Sample size of 1587 (529/arm) with overall one-sided 0.025 alpha provides 90% power. Interim analyses (reported here) tested at one-sided significance level of 0.001. P<0.001 indicates comparison crossed interim efficacy boundary. See Limitations and Caveats section. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Z-test | |
| Comments | ||
| Title | Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) |
|---|---|
| Description | Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
35.7
6.3%
|
22.3
3.9%
|
14.5
2.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.57 | |
| Confidence Interval |
(2-Sided) 97.5% 0.45 to 0.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.67 | |
| Confidence Interval |
(2-Sided) 97.5% 0.51 to 0.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.39 | |
| Confidence Interval |
(2-Sided) 97.5% 0.30 to 0.51 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
| Title | Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) |
|---|---|
| Description | Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
2.9
0.5%
|
2.4
0.4%
|
1.2
0.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.137 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.73 | |
| Confidence Interval |
(2-Sided) 97.5% 0.39 to 1.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.39 | |
| Confidence Interval |
(2-Sided) 97.5% 0.16 to 0.95 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.29 | |
| Confidence Interval |
(2-Sided) 97.5% 0.12 to 0.68 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
| Title | Percentage of Participants With Local Failure |
|---|---|
| Description | Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
3.1
0.5%
|
1.2
0.2%
|
0.4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.37 | |
| Confidence Interval |
(2-Sided) 97.5% 0.14 to 1.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.177 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.56 | |
| Confidence Interval |
(2-Sided) 97.5% 0.14 to 2.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.21 | |
| Confidence Interval |
(2-Sided) 97.5% 0.06 to 0.71 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
| Title | Percentage of Participants With Distant Metastasis |
|---|---|
| Description | Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
8.3
1.5%
|
5.9
1%
|
4.7
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.105 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 97.5% 0.49 to 1.22 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.62 | |
| Confidence Interval |
(2-Sided) 97.5% 0.36 to 1.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.48 | |
| Confidence Interval |
(2-Sided) 97.5% 0.29 to 0.81 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
| Title | Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality) |
|---|---|
| Description | Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. [Biochemical progression is indicated by any rise in PSA.] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
2.7
0.5%
|
1.1
0.2%
|
0.8
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.137 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 97.5% 0.35 to 1.43 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.141 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.68 | |
| Confidence Interval |
(2-Sided) 97.5% 0.30 to 1.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.47 | |
| Confidence Interval |
(2-Sided) 97.5% 0.21 to 1.03 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
| Title | Percentage of Participants Alive (Overall Mortality) |
|---|---|
| Description | Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | (Arm 1) Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | (Arm 2) Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | (Arm 3) Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Number (95% Confidence Interval) [percentage of participants] |
93.9
16.6%
|
96.1
16.6%
|
95.7
16.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.235 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.86 | |
| Confidence Interval |
(2-Sided) 97.5% 0.54 to 1.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.481 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.99 | |
| Confidence Interval |
(2-Sided) 97.5% 0.61 to 1.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.213 |
| Comments | One-sided significance level = 0.0125 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.85 | |
| Confidence Interval |
(2-Sided) 97.5% 0.53 to 1.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
| Title | Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT) |
|---|---|
| Description | Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis. |
| Time Frame | From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Grade 2+ |
18.8
3.3%
|
36.3
6.3%
|
43.6
7.6%
|
| Grade 3+ |
4.4
0.8%
|
8.7
1.5%
|
12.2
2.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | Acute grade 2+ acute adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | One-sided significance level = 0.025 | |
| Method | Regression, Logistic | |
| Comments | Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.47 | |
| Confidence Interval |
(2-Sided) 97.5% 1.81 to 3.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | Acute grade 2+ acute adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | One-sided significance level = 0.025 | |
| Method | Regression, Logistic | |
| Comments | Model was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.35 | |
| Confidence Interval |
(2-Sided) 97.5% 1.03 to 1.77 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | Acute grade 3+ acute adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | One-sided significance level = 0.025 | |
| Method | Regression, Logistic | |
| Comments | Univariate model was used due to the low number of events. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.04 | |
| Confidence Interval |
(2-Sided) 97.5% 1.16 to 3.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | Acute grade 3+ adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.025 |
| Comments | One-sided significance level = 0.025 | |
| Method | Regression, Logistic | |
| Comments | Univariate model was used due to the low number of events. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.47 | |
| Confidence Interval |
(2-Sided) 95% 0.975 to 2.27 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
| Title | Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT) |
|---|---|
| Description | Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring > 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. |
| Time Frame | AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | PBRT Alone | PBRT + STAD | PLNRT + PBRT + STAD |
|---|---|---|---|
| Arm/Group Description | Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). |
| Measure Participants | 564 | 578 | 574 |
| Grade 2+ |
52.8
9.4%
|
54.8
9.5%
|
58.6
10.2%
|
| Grade 3+ |
10.3
1.8%
|
11.4
2%
|
14.4
2.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | Late grade 2+ adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.268 |
| Comments | One-sided significance level = 0.025 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 97.5% 0.88 to 1.26 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | Late grade 2+ adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.101 |
| Comments | One-sided significance level = 0.025 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.10 | |
| Confidence Interval |
(2-Sided) 97.5% 0.93 to 1.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | PBRT Alone, PBRT + STAD |
|---|---|---|
| Comments | Late grade 3+ adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.119 |
| Comments | One-sided significance level = 0.025 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.22 | |
| Confidence Interval |
(2-Sided) 97.5% 0.83 to 1.80 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT Alone | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | PBRT + STAD, PLNRT + PBRT + STAD |
|---|---|---|
| Comments | Late grade 3+ adverse events | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.170 |
| Comments | One-sided significance level = 0.025 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.16 | |
| Confidence Interval |
(2-Sided) 97.5% 0.82 to 1.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference level = PBRT + STAD | |
| Title | Comparison of Disease-specific Health Related Quality of Life (HRQOL) Change by the Expanded Prostate Cancer Index Composite (EPIC), Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test A & B, and Controlled Oral Word Association Test (COWAT) |
|---|---|
| Description | |
| Time Frame | From the 6th week of radiation therapy to 5 years post radiation therapy. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25) |
|---|---|
| Description | |
| Time Frame | From the 6th week of radiation therapy to 5 years post radiation therapy. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY) |
|---|---|
| Description | |
| Time Frame | From the 6th week of radiation therapy to 5 years post radiation therapy. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Evaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D) |
|---|---|
| Description | |
| Time Frame | From the 6th week of radiation therapy to 5 years post radiation therapy. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints |
|---|---|
| Description | |
| Time Frame | Date of randomization to timepoint of the respective primary or secondary endpoint. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Assessment of the Relationship(s) Between the American Urological Association Symptom Index (AUA SI) and Urinary Morbidity (Adverse Event Terms: Urinary Frequency/Urgency) Using the CTCAE v. 3.0 Grading System |
|---|---|
| Description | |
| Time Frame | From the 6th week of radiation therapy to 5 years post radiation therapy. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Weekly during radiotherapy, at 3, 6, and 12 months after end of radiotherapy, every 6 months from end of treatment for 6 years, then annually until study completion. Maximum follow-up at time of reporting was 10.5 years. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Eligible participants who started study treatment and have adverse event data. | |||||
| Arm/Group Title | PBRT Alone | PBRT + STADT | PLNRT + PBRT + STADT | |||
| Arm/Group Description | Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration. | Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STADT) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STADT starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks). | |||
All Cause Mortality |
||||||
| PBRT Alone | PBRT + STADT | PLNRT + PBRT + STADT | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 48/547 (8.8%) | 43/563 (7.6%) | 43/563 (7.6%) | |||
Serious Adverse Events |
||||||
| PBRT Alone | PBRT + STADT | PLNRT + PBRT + STADT | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/547 (3.3%) | 29/563 (5.2%) | 23/563 (4.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Blood disorder | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Cardiac disorders | ||||||
| Cardiac disorder | 0/547 (0%) | 1/563 (0.2%) | 1/563 (0.2%) | |||
| Left ventricular failure | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Myocardial ischemia | 1/547 (0.2%) | 2/563 (0.4%) | 0/563 (0%) | |||
| Pericarditis | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Ventricular tachycardia | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Eye disorders | ||||||
| Eye disorder | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Anal pain | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Colonic obstruction | 0/547 (0%) | 0/563 (0%) | 2/563 (0.4%) | |||
| Diarrhea | 1/547 (0.2%) | 2/563 (0.4%) | 1/563 (0.2%) | |||
| Esophageal hemorrhage | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Esophageal mucositis | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Esophagitis | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Ileus | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Pancreatitis | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Proctitis | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Rectal hemorrhage | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Small intestinal obstruction | 0/547 (0%) | 1/563 (0.2%) | 1/563 (0.2%) | |||
| General disorders | ||||||
| Fatigue | 2/547 (0.4%) | 0/563 (0%) | 0/563 (0%) | |||
| Hepatobiliary disorders | ||||||
| Cholecystitis | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Infections and infestations | ||||||
| Bladder infection [with unknown ANC] | 1/547 (0.2%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Bone infection [with unknown ANC] | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Infection [other] | 0/547 (0%) | 1/563 (0.2%) | 1/563 (0.2%) | |||
| Sepsis [with unknown ANC] | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Urinary tract infection [with unknown ANC] | 3/547 (0.5%) | 0/563 (0%) | 0/563 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Intraoperative complications | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 0/547 (0%) | 2/563 (0.4%) | 2/563 (0.4%) | |||
| Aspartate aminotransferase increased | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/547 (0%) | 2/563 (0.4%) | 0/563 (0%) | |||
| Hyperglycemia | 0/547 (0%) | 1/563 (0.2%) | 1/563 (0.2%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Bone pain | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Joint pain | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Treatment related secondary malignancy | 0/547 (0%) | 2/563 (0.4%) | 0/563 (0%) | |||
| Nervous system disorders | ||||||
| Ischemia cerebrovascular | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Syncope vasovagal | 0/547 (0%) | 0/563 (0%) | 1/563 (0.2%) | |||
| Renal and urinary disorders | ||||||
| Bladder hemorrhage | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Bladder obstruction | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Bladder stenosis | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Cystitis | 2/547 (0.4%) | 4/563 (0.7%) | 3/563 (0.5%) | |||
| Hemorrhage urinary tract | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Renal hemorrhage | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Ureteric obstruction | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Urethral obstruction | 0/547 (0%) | 2/563 (0.4%) | 0/563 (0%) | |||
| Urethral stricture | 1/547 (0.2%) | 0/563 (0%) | 0/563 (0%) | |||
| Urinary frequency | 1/547 (0.2%) | 3/563 (0.5%) | 2/563 (0.4%) | |||
| Urinary incontinence | 4/547 (0.7%) | 1/563 (0.2%) | 2/563 (0.4%) | |||
| Urinary retention | 1/547 (0.2%) | 1/563 (0.2%) | 1/563 (0.2%) | |||
| Urogenital disorder | 5/547 (0.9%) | 2/563 (0.4%) | 1/563 (0.2%) | |||
| Reproductive system and breast disorders | ||||||
| Erectile dysfunction | 1/547 (0.2%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Pleural effusion | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Respiratory disorder | 0/547 (0%) | 1/563 (0.2%) | 1/563 (0.2%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Skin disorder | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Vascular disorders | ||||||
| Hot flashes | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Lymphocele | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
| Thrombosis | 0/547 (0%) | 1/563 (0.2%) | 0/563 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| PBRT Alone | PBRT + STADT | PLNRT + PBRT + STADT | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 433/547 (79.2%) | 492/563 (87.4%) | 509/563 (90.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Hemoglobin decreased | 32/547 (5.9%) | 73/563 (13%) | 80/563 (14.2%) | |||
| Gastrointestinal disorders | ||||||
| Constipation | 54/547 (9.9%) | 53/563 (9.4%) | 59/563 (10.5%) | |||
| Diarrhea | 110/547 (20.1%) | 127/563 (22.6%) | 219/563 (38.9%) | |||
| Gastrointestinal disorder | 36/547 (6.6%) | 36/563 (6.4%) | 33/563 (5.9%) | |||
| Hemorrhoids | 26/547 (4.8%) | 29/563 (5.2%) | 33/563 (5.9%) | |||
| Proctitis | 62/547 (11.3%) | 55/563 (9.8%) | 66/563 (11.7%) | |||
| Rectal hemorrhage | 43/547 (7.9%) | 50/563 (8.9%) | 48/563 (8.5%) | |||
| General disorders | ||||||
| Fatigue | 148/547 (27.1%) | 211/563 (37.5%) | 217/563 (38.5%) | |||
| Pain [other] | 30/547 (5.5%) | 31/563 (5.5%) | 43/563 (7.6%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 8/547 (1.5%) | 35/563 (6.2%) | 23/563 (4.1%) | |||
| Aspartate aminotransferase increased | 11/547 (2%) | 35/563 (6.2%) | 20/563 (3.6%) | |||
| Leukopenia | 32/547 (5.9%) | 29/563 (5.2%) | 40/563 (7.1%) | |||
| Lymphopenia | 28/547 (5.1%) | 26/563 (4.6%) | 50/563 (8.9%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 30/547 (5.5%) | 35/563 (6.2%) | 26/563 (4.6%) | |||
| Psychiatric disorders | ||||||
| Libido decreased | 35/547 (6.4%) | 67/563 (11.9%) | 83/563 (14.7%) | |||
| Renal and urinary disorders | ||||||
| Cystitis | 69/547 (12.6%) | 72/563 (12.8%) | 71/563 (12.6%) | |||
| Hemorrhage urinary tract | 36/547 (6.6%) | 29/563 (5.2%) | 36/563 (6.4%) | |||
| Urinary frequency | 281/547 (51.4%) | 333/563 (59.1%) | 348/563 (61.8%) | |||
| Urinary incontinence | 237/547 (43.3%) | 215/563 (38.2%) | 239/563 (42.5%) | |||
| Urinary retention | 69/547 (12.6%) | 69/563 (12.3%) | 78/563 (13.9%) | |||
| Urogenital disorder | 77/547 (14.1%) | 64/563 (11.4%) | 80/563 (14.2%) | |||
| Reproductive system and breast disorders | ||||||
| Erectile dysfunction | 155/547 (28.3%) | 185/563 (32.9%) | 202/563 (35.9%) | |||
| Vascular disorders | ||||||
| Hot flashes | 36/547 (6.6%) | 327/563 (58.1%) | 325/563 (57.7%) | |||
Limitations/Caveats
Three interim analyses were planned when there were 397, 794, and 1191 eligible patients with five years of potential follow-up from the randomization date. Due to findings from the third interim analysis, the data monitoring committee recommended that study results be reported early for all arms, while recognizing that the originally planned full analysis will provide additional insight for the Arm 3 vs. Arm 2 comparison.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
| Name/Title | Wendy Seiferheld |
|---|---|
| Organization | NRG Oncology |
| Phone | 215-574-3208 |
| seiferheldw@nrgoncology.org |
Responsible Party:
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00567580
Other Study ID Numbers:
- RTOG-0534
- CDR0000577574
- NCI-2009-00733
- NCT01312974
First Posted:
Dec 5, 2007
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022