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
Enrollment
460
Locations
3
Arms
3.9
Patients Per Site

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 DiseaseIntervention/TreatmentPhase
  • Radiation: PBRT
  • Radiation: PLNRT
  • Drug: AA
  • Drug: LHRH agonist
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

ArmIntervention/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:
  • Prostate bed radiotherapy
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity modulated RT (IMRT)
  • 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:
  • Prostate bed radiotherapy
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity modulated RT (IMRT)
  • 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:
  • flutamide
  • bicalutamide
  • 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:
  • leuprolide
  • goserelin
  • buserelin
  • triptorelin
  • 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:
  • Prostate bed radiotherapy
  • Three-Dimensional Conformal Radiation Therapy (3D-CRT)
  • Intensity modulated RT (IMRT)
  • Radiation: PLNRT
    1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.
    Other Names:
  • Pelvic lymph node radiotherapy
  • 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:
  • flutamide
  • bicalutamide
  • 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:
  • leuprolide
  • goserelin
  • buserelin
  • triptorelin
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.]

    10. 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.]

    11. 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.]

    12. 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.]

    13. 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.]

    14. 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:
    1. 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.

    1. 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;

    2. 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;

    1. Prostatectomy Gleason score of 9 or less;

    2. Zubrod Performance Status of 0-1;

    3. Age ≥ 18;

    4. 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.

    1. 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).

    1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x the upper limit of normal within 90 days prior to registration;

    2. 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);

    3. Patients must sign a study-specific informed consent prior to study entry.

    Exclusion Criteria:
    1. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;

    2. 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;

    3. 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;

    4. 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);

    5. Neoadjuvant chemotherapy before or after prostatectomy;

    6. Prior chemotherapy for any other disease site if given within 5 years prior to registration;

    7. Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;

    8. Prior pelvic radiotherapy;

    9. 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];

    10. 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.

    1. Prior allergic reaction to the study drug(s) involved in this protocol.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1UAB Comprehensive Cancer CenterBirminghamAlabamaUnited States35294
    2Fairbanks Cancer Treatment Center at Fairbanks Memorial HospitalFairbanksAlaskaUnited States99701
    3Arizona Center for Cancer Care - PeoriaPeoriaArizonaUnited States85381
    4Arizona Oncology Services FoundationPhoenixArizonaUnited States85013
    5Arizona Oncology - TucsonTucsonArizonaUnited States85704
    6Auburn Radiation OncologyAuburnCaliforniaUnited States95603
    7Peninsula Medical CenterBurlingameCaliforniaUnited States94010
    8Radiation Oncology Centers - Cameron ParkCameron ParkCaliforniaUnited States95682
    9Mercy Cancer Center at Mercy San Juan Medical CenterCarmichaelCaliforniaUnited States95608
    10East Bay Radiation Oncology CenterCastro ValleyCaliforniaUnited States94546
    11Valley Medical Oncology Consultants - Castro ValleyCastro ValleyCaliforniaUnited States94546
    12Enloe Cancer Center at Enloe Medical CenterChicoCaliforniaUnited States95926
    13Valley Medical OncologyFremontCaliforniaUnited States94538
    14Washington Township HospitalFremontCaliforniaUnited States94538
    15California Cancer Center - Woodward Park OfficeFresnoCaliforniaUnited States93720
    16Cancer Care AssociatesFresnoCaliforniaUnited States93720
    17Rebecca and John Moores UCSD Cancer CenterLa JollaCaliforniaUnited States92093-0658
    18Veterans Affairs Medical Center - Long BeachLong BeachCaliforniaUnited States90822
    19Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90048
    20USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCaliforniaUnited States90089-9181
    21Contra Costa Regional Medical CenterMartinezCaliforniaUnited States94553-3156
    22Providence Holy Cross Cancer CenterMission HillsCaliforniaUnited States91346-9600
    23Memorial Medical CenterModestoCaliforniaUnited States95355
    24El Camino Hospital Cancer CenterMountain ViewCaliforniaUnited States94040
    25Sutter Health - Western Division Cancer Research GroupNovatoCaliforniaUnited States94945
    26Alta Bates Summit Medical Center - Summit CampusOaklandCaliforniaUnited States94609
    27Bay Area Breast Surgeons, IncorporatedOaklandCaliforniaUnited States94609
    28CCOP - Bay Area Tumor InstituteOaklandCaliforniaUnited States94609
    29Larry G Strieff MD Medical CorporationOaklandCaliforniaUnited States94609
    30Tom K Lee, IncorporatedOaklandCaliforniaUnited States94609
    31St. Joseph Hospital Regional Cancer Center - OrangeOrangeCaliforniaUnited States92868
    32Feather River Hospital Cancer CenterParadiseCaliforniaUnited States95969
    33Radiation Oncology Center - RosevilleRosevilleCaliforniaUnited States95661
    34Radiological Associates of Sacramento Medical Group, IncorporatedSacramentoCaliforniaUnited States95815
    35University of California Davis Cancer CenterSacramentoCaliforniaUnited States95817
    36Mercy General HospitalSacramentoCaliforniaUnited States95819
    37Saint Helena HospitalSaint HelenaCaliforniaUnited States94574
    38UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCaliforniaUnited States94115
    39California Pacific Medical Center - California CampusSan FranciscoCaliforniaUnited States94118
    40Doctors Medical Center - San Pablo CampusSan PabloCaliforniaUnited States94806
    41Solano Radiation Oncology CenterVacavilleCaliforniaUnited States95687
    42Sutter Solano Medical CenterVallejoCaliforniaUnited States94589
    43Aurora Presbyterian HospitalAuroraColoradoUnited States80012
    44Rocky Mountain Cancer Centers - AuroraAuroraColoradoUnited States80012
    45University of Colorado Cancer Center at UC Health Sciences CenterAuroraColoradoUnited States80045
    46Boulder Community HospitalBoulderColoradoUnited States80301-9019
    47St. Anthony Central HospitalDenverColoradoUnited States80204
    48Porter Adventist HospitalDenverColoradoUnited States80210
    49Presbyterian - St. Luke's Medical CenterDenverColoradoUnited States80218
    50St. Joseph HospitalDenverColoradoUnited States80218
    51Swedish Medical CenterEnglewoodColoradoUnited States80110
    52North Colorado Medical CenterGreeleyColoradoUnited States80631
    53Hope Cancer Care Center at Longmont United HospitalLongmontColoradoUnited States80501
    54McKee Medical CenterLovelandColoradoUnited States80539
    55St. Mary - Corwin Regional Medical CenterPuebloColoradoUnited States81004
    56North Suburban Medical CenterThorntonColoradoUnited States80229
    57Exempla Lutheran Medical CenterWheat RidgeColoradoUnited States80033
    58Middlesex Hospital Cancer CenterMiddletownConnecticutUnited States06457
    59George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew BritainConnecticutUnited States06050
    60William W. Backus HospitalNorwichConnecticutUnited States06360
    61CCOP - Christiana Care Health ServicesNewarkDelawareUnited States19713
    62Washington Cancer Institute at Washington Hospital CenterWashingtonDistrict of ColumbiaUnited States20010
    63University of Florida Shands Cancer CenterGainesvilleFloridaUnited States32610-0232
    64Integrated Community Oncology NetworkJacksonville BeachFloridaUnited States32250
    65Baptist Cancer Institute - JacksonvilleJacksonvilleFloridaUnited States32207
    66Integrated Community Oncology Network at Southside Cancer CenterJacksonvilleFloridaUnited States32207
    67Baptist Medical Center SouthJacksonvilleFloridaUnited States32258
    68Baptist-South Miami Regional Cancer ProgramMiamiFloridaUnited States33176
    69Integrated Community Oncology Network - Orange ParkOrange ParkFloridaUnited States32073
    70Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlandoFloridaUnited States32803-1273
    71Florida Cancer Center - PalatkaPalatkaFloridaUnited States32177
    72Flagler Cancer CenterSaint AugustineFloridaUnited States32086
    73Veterans Affairs Medical Center - TampaTampaFloridaUnited States33612
    74Emory Crawford Long HospitalAtlantaGeorgiaUnited States30308
    75Piedmont HospitalAtlantaGeorgiaUnited States30309
    76Winship Cancer Institute of Emory UniversityAtlantaGeorgiaUnited States30322
    77Northside Hospital Cancer CenterAtlantaGeorgiaUnited States30342-1611
    78John B. Amos Cancer CenterColumbusGeorgiaUnited States31904
    79Northside Hospital-ForsythCummingGeorgiaUnited States30041
    80Piedmont Fayette HospitalFayettevilleGeorgiaUnited States30214
    81Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannahGeorgiaUnited States31405
    82Kapiolani Medical Center at Pali Momi'AieaHawaiiUnited States96701
    83Cancer Research Center of HawaiiHonoluluHawaiiUnited States96813
    84Queen's Cancer Institute at Queen's Medical CenterHonoluluHawaiiUnited States96813
    85Straub Clinic and Hospital, IncorporatedHonoluluHawaiiUnited States96813
    86Hawaii Medical Center - EastHonoluluHawaiiUnited States96817
    87Pacific Cancer Institute - MauiWailukuHawaiiUnited States96793
    88Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoiseIdahoUnited States83706
    89Mount Sinai Hospital Medical CenterChicagoIllinoisUnited States60608
    90Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinoisUnited States60611-3013
    91University of Chicago Cancer Research CenterChicagoIllinoisUnited States60637-1470
    92Creticos Cancer Center at Advocate Illinois Masonic Medical CenterChicagoIllinoisUnited States60657
    93Decatur Memorial Hospital Cancer Care InstituteDecaturIllinoisUnited States62526
    94Leonard C. Ferguson Cancer CenterFreeportIllinoisUnited States61032
    95Ingalls Cancer Care Center at Ingalls Memorial HospitalHarveyIllinoisUnited States60426
    96Veterans Affairs Medical Center - HinesHinesIllinoisUnited States60141
    97Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywoodIllinoisUnited States60153
    98Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMolineIllinoisUnited States61265
    99Cancer Institute at St. John's HospitalSpringfieldIllinoisUnited States62702
    100Regional Cancer Center at Memorial Medical CenterSpringfieldIllinoisUnited States62781-0001
    101Elkhart General HospitalElkhartIndianaUnited States46515
    102Radiation Oncology Associates SouthwestFort WayneIndianaUnited States46804
    103Parkview Regional Cancer Center at Parkview HealthFort WayneIndianaUnited States46805
    104Center for Cancer Care at Goshen General HospitalGoshenIndianaUnited States46526
    105Howard Community HospitalKokomoIndianaUnited States46904
    106Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa PorteIndianaUnited States46350
    107Saint Joseph Regional Medical CenterMishawakaIndianaUnited States46545-1470
    108CCOP - Northern Indiana CR ConsortiumSouth BendIndianaUnited States46601
    109Memorial Hospital of South BendSouth BendIndianaUnited States46601
    110CCOP - Iowa Oncology Research AssociationDes MoinesIowaUnited States50309
    111John Stoddard Cancer Center at Iowa Methodist Medical CenterDes MoinesIowaUnited States50309
    112Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes MoinesIowaUnited States50309
    113Medical Oncology and Hematology Associates at Mercy Cancer CenterDes MoinesIowaUnited States50314
    114Mercy Cancer Center at Mercy Medical Center - Des MoinesDes MoinesIowaUnited States50314
    115John Stoddard Cancer Center at Iowa Lutheran HospitalDes MoinesIowaUnited States50316
    116Siouxland Hematology-Oncology Associates, LLPSioux CityIowaUnited States51101
    117Mercy Medical Center - Sioux CitySioux CityIowaUnited States51102
    118St. Luke's Regional Medical CenterSioux CityIowaUnited States51104
    119Cancer Center of Kansas, PA - Dodge CityDodge CityKansasUnited States67801
    120Cancer Center of Kansas, PA - El DoradoEl DoradoKansasUnited States67042
    121Lawrence Memorial HospitalLawrenceKansasUnited States66044
    122Cancer Center of Kansas, PA - WellingtonWellingtonKansasUnited States67152
    123Associates in Womens Health, PA - North ReviewWichitaKansasUnited States67208
    124Cancer Center of Kansas, PA - Medical Arts TowerWichitaKansasUnited States67208
    125Cancer Center of Kansas, PA - WichitaWichitaKansasUnited States67214
    126CCOP - WichitaWichitaKansasUnited States67214
    127Via Christi Cancer Center at Via Christi Regional Medical CenterWichitaKansasUnited States67214
    128Wesley Medical CenterWichitaKansasUnited States67214
    129Cancer Center of Kansas, PA - WinfieldWinfieldKansasUnited States67156
    130Lucille P. Markey Cancer Center at University of KentuckyLexingtonKentuckyUnited States40536-0093
    131Norton Suburban HospitalLouisvilleKentuckyUnited States40207
    132Tulane Cancer Center Office of Clinical ResearchAlexandriaLouisianaUnited States71315-3198
    133Mary Bird Perkins Cancer Center - Baton RougeBaton RougeLouisianaUnited States70809
    134MBCCOP - LSU Health Sciences CenterNew OrleansLouisianaUnited States70112
    135Medical Center of Louisiana - New OrleansNew OrleansLouisianaUnited States70112
    136CCOP - OchsnerNew OrleansLouisianaUnited States70121
    137Greenebaum Cancer Center at University of Maryland Medical CenterBaltimoreMarylandUnited States21201
    138Greater Baltimore Medical Center Cancer CenterBaltimoreMarylandUnited States21204
    139St. Agnes Hospital Cancer CenterBaltimoreMarylandUnited States21229
    140Central Maryland Oncology CenterColumbiaMarylandUnited States21044
    141Tate Cancer Center at Baltimore Washington Medical CenterGlen BurnieMarylandUnited States21061
    142Holy Cross HospitalSilver SpringMarylandUnited States20910
    143Massachusetts General HospitalBostonMassachusettsUnited States02114
    144Dana-Farber/Brigham and Women's Cancer CenterBostonMassachusettsUnited States02115
    145Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBostonMassachusettsUnited States02115
    146Boston University Cancer Research CenterBostonMassachusettsUnited States02118
    147Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States02215
    148Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall RiverMassachusettsUnited States02721
    149Cape Cod HospitalHyannisMassachusettsUnited States02601
    150Lowell General HospitalLowellMassachusettsUnited States01854
    151Hickman Cancer Center at Bixby Medical CenterAdrianMichiganUnited States49221
    152Saint Joseph Mercy Cancer CenterAnn ArborMichiganUnited States48106-0995
    153CCOP - Michigan Cancer Research ConsortiumAnn ArborMichiganUnited States48106
    154University of Michigan Comprehensive Cancer CenterAnn ArborMichiganUnited States48109-0942
    155Henry Ford Macomb HospitalClinton TownshipMichiganUnited States48038
    156Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearbornMichiganUnited States48123-2500
    157Josephine Ford Cancer Center at Henry Ford HospitalDetroitMichiganUnited States48202
    158Genesys Hurley Cancer InstituteFlintMichiganUnited States48503
    159Hurley Medical CenterFlintMichiganUnited States48503
    160McLaren Cancer InstituteFlintMichiganUnited States48532
    161Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe WoodsMichiganUnited States48236
    162Foote Memorial HospitalJacksonMichiganUnited States49201
    163Borgess Medical CenterKalamazooMichiganUnited States49001
    164West Michigan Cancer CenterKalamazooMichiganUnited States49007-3731
    165Bronson Methodist HospitalKalamazooMichiganUnited States49007
    166Sparrow Regional Cancer CenterLansingMichiganUnited States48912-1811
    167St. Mary Mercy HospitalLivoniaMichiganUnited States48154
    168St. Joseph Mercy OaklandPontiacMichiganUnited States48341-2985
    169Mercy Regional Cancer Center at Mercy HospitalPort HuronMichiganUnited States48060
    170William Beaumont Hospital - Royal Oak CampusRoyal OakMichiganUnited States48073
    171Seton Cancer Institute at Saint Mary's - SaginawSaginawMichiganUnited States48601
    172Lakeland Regional Cancer Care Center - St. JosephSaint JosephMichiganUnited States49085
    173St. John Macomb HospitalWarrenMichiganUnited States48093
    174MeritCare BemidjiBemidjiMinnesotaUnited States56601
    175Fairview Ridges HospitalBurnsvilleMinnesotaUnited States55337
    176Mercy and Unity Cancer Center at Mercy HospitalCoon RapidsMinnesotaUnited States55433
    177St. Luke's Hospital Cancer Care CenterDuluthMinnesotaUnited States55805
    178Fairview Southdale HospitalEdinaMinnesotaUnited States55435
    179Mercy and Unity Cancer Center at Unity HospitalFridleyMinnesotaUnited States55432
    180Immanuel St. Joseph'sMankatoMinnesotaUnited States56002
    181HealthEast Cancer Care at St. John's HospitalMaplewoodMinnesotaUnited States55109
    182Minnesota Oncology - MaplewoodMaplewoodMinnesotaUnited States55109
    183Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolisMinnesotaUnited States55407
    184Hennepin County Medical Center - MinneapolisMinneapolisMinnesotaUnited States55415
    185Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdaleMinnesotaUnited States55422-2900
    186Mayo Clinic Cancer CenterRochesterMinnesotaUnited States55905
    187CCOP - Metro-MinnesotaSaint Louis ParkMinnesotaUnited States55416
    188Park Nicollet Cancer CenterSaint Louis ParkMinnesotaUnited States55416
    189Regions Hospital Cancer Care CenterSaint PaulMinnesotaUnited States55101
    190United HospitalSaint PaulMinnesotaUnited States55102
    191St. Francis Cancer Center at St. Francis Medical CenterShakopeeMinnesotaUnited States55379
    192Ridgeview Medical CenterWaconiaMinnesotaUnited States55387
    193Willmar Cancer Center at Rice Memorial HospitalWillmarMinnesotaUnited States56201
    194Minnesota Oncology - WoodburyWoodburyMinnesotaUnited States55125
    195Regional Cancer Center at Singing River HospitalPascagoulaMississippiUnited States39581
    196Cancer Institute of Cape Girardeau, LLCCape GirardeauMissouriUnited States63703
    197Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSaint LouisMissouriUnited States63110
    198Barnes-Jewish West County HospitalSaint LouisMissouriUnited States63141
    199Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. PetersSaint PetersMissouriUnited States63376
    200CCOP - Montana Cancer ConsortiumBillingsMontanaUnited States59101
    201Billings Clinic - DowntownBillingsMontanaUnited States59107-7000
    202Bozeman Deaconess Cancer CenterBozemanMontanaUnited States59715
    203Great Falls Clinic - Main FacilityGreat FallsMontanaUnited States59405
    204Sletten Cancer Institute at Benefis HealthcareGreat FallsMontanaUnited States59405
    205Cancer Resource Center - LincolnLincolnNebraskaUnited States68510
    206Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical CenterLincolnNebraskaUnited States68510
    207CCOP - Missouri Valley Cancer ConsortiumOmahaNebraskaUnited States68106
    208Methodist Estabrook Cancer CenterOmahaNebraskaUnited States68114
    209Immanuel Medical CenterOmahaNebraskaUnited States68122
    210Alegant Health Cancer Center at Bergan Mercy Medical CenterOmahaNebraskaUnited States68124
    211Lakeside HospitalOmahaNebraskaUnited States68130
    212Creighton University Medical CenterOmahaNebraskaUnited States68131-2197
    213Nebraska Medical CenterOmahaNebraskaUnited States68198
    214CCOP - Nevada Cancer Research FoundationLas VegasNevadaUnited States89106
    215Center for Cancer Care at Exeter HospitalExeterNew HampshireUnited States03833
    216Kingsbury Center for Cancer Care at Cheshire Medical CenterKeeneNew HampshireUnited States03431
    217Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanonNew HampshireUnited States03756-0002
    218Memorial Sloan-Kettering Cancer Center - Basking RidgeBasking RidgeNew JerseyUnited States07920
    219AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland CampusGallowayNew JerseyUnited States08240
    220Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarltonNew JerseyUnited States08053
    221Saint Peter's University HospitalNew BrunswickNew JerseyUnited States08901
    222Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew BrunswickNew JerseyUnited States08903
    223Capital Health Regional Cancer CenterPenningtonNew JerseyUnited States08534
    224Valley Hospital - RidgewoodRidgewoodNew JerseyUnited States07450
    225Somerset Medical CenterSomervilleNew JerseyUnited States08876
    226Frederick R. and Betty M. Smith Cancer Treatment CenterSpartaNew JerseyUnited States07871
    227Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVinelandNew JerseyUnited States08360
    228Cancer Institute of New Jersey at Cooper - VoorheesVoorheesNew JerseyUnited States08043
    229Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorheesNew JerseyUnited States08043
    230New Mexico Cancer CenterAlbuquerqueNew MexicoUnited States87109
    231University of New Mexico Cancer CenterAlbuquerqueNew MexicoUnited States87131-5636
    232University of New Mexico Cancer Center - SouthLas CrucesNew MexicoUnited States88011
    233New York Oncology Hematology, PC at Albany Regional Cancer CareAlbanyNew YorkUnited States12206
    234New York Methodist HospitalBrooklynNew YorkUnited States11215
    235Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263-0001
    236Sands Cancer CenterCanandaiguaNew YorkUnited States14424
    237Memorial Sloan-Kettering Cancer CenterCommackNew YorkUnited States11725
    238Stich Radiation Center at NewYork-Presbyterian Hospital/Weill Cornell Medical CenterNew YorkNew YorkUnited States10021
    239St. Luke's - Roosevelt Hospital Center - St.Luke's DivisionNew YorkNew YorkUnited States10025
    240Dyson Center for Cancer Care at Vassar Brothers Medical CenterPoughkeepsieNew YorkUnited States12601-3990
    241Hudson Valley Oncology AssociatesPoughkeepsieNew YorkUnited States12601
    242Highland Hospital of RochesterRochesterNew YorkUnited States14620
    243Lipson Cancer and Blood Center at Rochester General HospitalRochesterNew YorkUnited States14621
    244University Radiation Oncology at Parkridge HospitalRochesterNew YorkUnited States14626
    245James P. Wilmot Cancer Center at University of Rochester Medical CenterRochesterNew YorkUnited States14642
    246Memorial Sloan-Kettering Cancer Center - Rockville CentreRockville CentreNew YorkUnited States11570
    247Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy HollowNew YorkUnited States10591
    248Randolph HospitalAsheboroNorth CarolinaUnited States27203-5400
    249Mission Hospitals - Memorial CampusAshevilleNorth CarolinaUnited States28801
    250Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth CarolinaUnited States27599-7295
    251Blumenthal Cancer Center at Carolinas Medical CenterCharlotteNorth CarolinaUnited States28232-2861
    252Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboroNorth CarolinaUnited States27403-1198
    253Coleman Radiation Oncology Center at Carter General HospitalMorehead CityNorth CarolinaUnited States28557
    254CarolinaEast Cancer CareNew BernNorth CarolinaUnited States28560
    255FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurstNorth CarolinaUnited States28374
    256Rex Cancer Center at Rex HospitalRaleighNorth CarolinaUnited States27607
    257Annie Penn Cancer CenterReidsvilleNorth CarolinaUnited States27320
    258South Atlantic Radiation Oncology, LLCSupplyNorth CarolinaUnited States28462
    259Coastal Carolina Radiation Oncology CenterWilmingtonNorth CarolinaUnited States28401
    260Zimmer Cancer Center at New Hanover Regional Medical CenterWilmingtonNorth CarolinaUnited States28401
    261MeritCare BroadwayFargoNorth DakotaUnited States58102
    262CCOP - MeritCare HospitalFargoNorth DakotaUnited States58122
    263Roger Maris Cancer Center at MeritCare HospitalFargoNorth DakotaUnited States58122
    264Altru Cancer Center at Altru HospitalGrand ForksNorth DakotaUnited States58201
    265McDowell Cancer Center at Akron General Medical CenterAkronOhioUnited States44307
    266Summa Center for Cancer Care at Akron City HospitalAkronOhioUnited States44309-2090
    267Barberton Citizens HospitalBarbertonOhioUnited States44203
    268Aultman Cancer Center at Aultman HospitalCantonOhioUnited States44710-1799
    269Adena Regional Medical CenterChillicotheOhioUnited States45601
    270Case Comprehensive Cancer CenterClevelandOhioUnited States44106-5065
    271Cleveland Clinic Cancer Center at Fairview HospitalClevelandOhioUnited States44111
    272Cleveland Clinic Taussig Cancer CenterClevelandOhioUnited States44195
    273Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbusOhioUnited States43210-1240
    274Riverside Methodist Hospital Cancer CareColumbusOhioUnited States43214-3998
    275CCOP - ColumbusColumbusOhioUnited States43215
    276Grant Medical Center Cancer CareColumbusOhioUnited States43215
    277Mount Carmel Health - West HospitalColumbusOhioUnited States43222
    278Doctors Hospital at Ohio HealthColumbusOhioUnited States43228
    279Grady Memorial HospitalDelawareOhioUnited States43015
    280Community Cancer CenterElyriaOhioUnited States44035
    281Hematology Oncology CenterElyriaOhioUnited States44035
    282Cleveland Clinic Cancer CenterIndependenceOhioUnited States44131
    283Lima Memorial HospitalLimaOhioUnited States45804
    284Strecker Cancer Center at Marietta Memorial HospitalMariettaOhioUnited States45750
    285Northwest Ohio Oncology CenterMaumeeOhioUnited States43537-1839
    286Hillcrest Cancer Center at Hillcrest HospitalMayfield HeightsOhioUnited States44124
    287Lake/University Ireland Cancer CenterMentorOhioUnited States44060
    288Southwest General Health CenterMiddleburg HeightsOhioUnited States44130
    289Licking Memorial Cancer Care Program at Licking Memorial HospitalNewarkOhioUnited States43055
    290UHHS Chagrin Highlands Medical CenterOrange VillageOhioUnited States44122
    291St. Charles Mercy HospitalOregonOhioUnited States43616
    292Parma Community General HospitalParmaOhioUnited States44129
    293Southern Ohio Medical Center Cancer CenterPortsmouthOhioUnited States45662
    294Cancer Care Center, IncorporatedSalemOhioUnited States44460
    295North Coast Cancer Care, IncorporatedSanduskyOhioUnited States44870
    296Community Hospital of Springfield and Clark CountySpringfieldOhioUnited States45505
    297Tony Teramana Cancer CenterSteubenvilleOhioUnited States43952
    298Cleveland Clinic Foundation - StrongsvilleStrongsvilleOhioUnited States44136
    299Flower Hospital Cancer CenterSylvaniaOhioUnited States43560
    300Mercy Hospital of TiffinTiffinOhioUnited States44883
    301Toledo HospitalToledoOhioUnited States43606
    302St. Vincent Mercy Medical CenterToledoOhioUnited States43608
    303Medical University of Ohio Cancer CenterToledoOhioUnited States43614
    304CCOP - Toledo Community HospitalToledoOhioUnited States43617
    305St. Anne Mercy HospitalToledoOhioUnited States43623
    306Toledo Clinic, Incorporated - Main ClinicToledoOhioUnited States43623
    307Mount Carmel St. Ann's Cancer CenterWestervilleOhioUnited States43081
    308UHHS Westlake Medical CenterWestlakeOhioUnited States44145
    309Cancer Treatment CenterWoosterOhioUnited States44691
    310Cleveland Clinic - WoosterWoosterOhioUnited States44691
    311Genesis - Good Samaritan HospitalZanesvilleOhioUnited States43701
    312Oklahoma University Cancer InstituteOklahoma CityOklahomaUnited States73104
    313Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsaOklahomaUnited States74136
    314Willamette Valley Cancer Center - EugeneEugeneOregonUnited States97401
    315Three Rivers Community HospitalGrants PassOregonUnited States97527
    316Legacy Mount Hood Medical CenterGreshamOregonUnited States97030
    317Dubs Cancer Center at Rogue Valley Medical CenterMedfordOregonUnited States97504
    318Providence Cancer Center at PMCCMedfordOregonUnited States97504
    319Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortlandOregonUnited States97210
    320Salem Hospital Regional Cancer Care ServicesSalemOregonUnited States97309-5014
    321Legacy Meridian Park HospitalTualatinOregonUnited States97062
    322Rosenfeld Cancer Center at Abington Memorial HospitalAbingtonPennsylvaniaUnited States19001
    323UPMC Cancer Center at Beaver Medical CenterBeaverPennsylvaniaUnited States15009
    324St. Luke's Cancer Network at St. Luke's HospitalBethlehemPennsylvaniaUnited States18015
    325Bryn Mawr HospitalBryn MawrPennsylvaniaUnited States19010
    326UPMC Cancer Center at Jefferson Regional Medical CenterClairtonPennsylvaniaUnited States15025
    327Geisinger Cancer Institute at Geisinger HealthDanvillePennsylvaniaUnited States17822-0001
    328Northeast Radiation Oncology CenterDunmorePennsylvaniaUnited States18512
    329Adams Cancer CenterGettysburgPennsylvaniaUnited States17325
    330UPMC Cancer Center - Arnold Palmer PavilionGreensburgPennsylvaniaUnited States15601
    331Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHersheyPennsylvaniaUnited States17033-0850
    332UPMC Cancer Center at the John P. Murtha PavilionJohnstownPennsylvaniaUnited States15901
    333Lancaster General HospitalLancasterPennsylvaniaUnited States17604
    334St. Mary Regional Cancer CenterLanghornePennsylvaniaUnited States19047
    335UPMC Cancer Center at UPMC McKeesportMcKeesportPennsylvaniaUnited States15132
    336Upper Delaware Valley Cancer CenterMilfordPennsylvaniaUnited States18337
    337Intercommunity Cancer CenterMonroevillePennsylvaniaUnited States15146
    338UPMC - MoonMoonPennsylvaniaUnited States15108
    339Alle-Kiski Medical CenterNatrona HeightsPennsylvaniaUnited States15065
    340UPMC Cancer Center - Natrona HeightsNatrona HeightsPennsylvaniaUnited States15065
    341Jameson Memorial Hospital - North CampusNew CastlePennsylvaniaUnited States16105
    342Cancer Center of Paoli Memorial HospitalPaoliPennsylvaniaUnited States19301-1792
    343Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphiaPennsylvaniaUnited States19107-5541
    344Fox Chase Cancer Center - PhiladelphiaPhiladelphiaPennsylvaniaUnited States19111-2497
    345Albert Einstein Cancer CenterPhiladelphiaPennsylvaniaUnited States19141
    346Allegheny Cancer Center at Allegheny General HospitalPittsburghPennsylvaniaUnited States15212
    347UPMC - ShadysidePittsburghPennsylvaniaUnited States15213-2582
    348UPMC Cancer Center at Magee-Womens HospitalPittsburghPennsylvaniaUnited States15213
    349UPMC Cancer Center at UPMC PresbyterianPittsburghPennsylvaniaUnited States15213
    350UPMC Cancer Center at UPMC St. MargaretPittsburghPennsylvaniaUnited States15215
    351UPMC Cancer Center at UPMC PassavantPittsburghPennsylvaniaUnited States15237
    352UPMC Cancer Center - Upper St. ClairPittsburghPennsylvaniaUnited States15243
    353St. Joseph Medical CenterReadingPennsylvaniaUnited States19605
    354McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReadingPennsylvaniaUnited States19612-6052
    355Washington Hospital Cancer CenterWashingtonPennsylvaniaUnited States15301
    356Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-BarrePennsylvaniaUnited States18711
    357CCOP - Main Line HealthWynnewoodPennsylvaniaUnited States19096
    358Lankenau Cancer Center at Lankenau HospitalWynnewoodPennsylvaniaUnited States19096
    359York Cancer Center at Apple Hill Medical CenterYorkPennsylvaniaUnited States17405
    360AnMed Cancer CenterAndersonSouth CarolinaUnited States29621
    361Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425
    362Cancer Centers of the Carolinas - Faris RoadGreenvilleSouth CarolinaUnited States29605
    363Cancer Centers of the Carolinas - Grove CommonsGreenvilleSouth CarolinaUnited States29605
    364Cancer Centers of the Carolinas - EastsideGreenvilleSouth CarolinaUnited States29615
    365CCOP - GreenvilleGreenvilleSouth CarolinaUnited States29615
    366Cancer Centers of the Carolinas - Greer Medical OncologyGreerSouth CarolinaUnited States29650
    367Cancer Centers of the Carolinas - Greer Radiation OncologyGreerSouth CarolinaUnited States29650
    368Hilton Head Radiation Oncology CenterHilton Head IslandSouth CarolinaUnited States29926
    369Cancer Centers of the Carolinas - SenecaSenecaSouth CarolinaUnited States29672
    370CCOP - Upstate CarolinaSpartanburgSouth CarolinaUnited States29303
    371Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburgSouth CarolinaUnited States29303
    372Cancer Centers of the Carolinas - SpartanburgSpartanburgSouth CarolinaUnited States29307
    373Rapid City Regional HospitalRapid CitySouth DakotaUnited States57701
    374West Tennessee Cancer Center at Jackson-Madison County General HospitalJacksonTennesseeUnited States38301
    375Texas Oncology, PA at Harris Center HEBBedfordTexasUnited States76022
    376Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallasTexasUnited States75390
    377Texas Oncology, PA at Texas Cancer Center - Denton SouthDentonTexasUnited States76210
    378Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort WorthTexasUnited States76104
    379University of Texas Medical BranchGalvestonTexasUnited States77555-0361
    380Memorial Hermann Hospital - Memorial CityHoustonTexasUnited States77024
    381Texas Oncology, PA at Lake Vista Cancer CenterLewisvilleTexasUnited States75067
    382Longview Cancer CenterLongviewTexasUnited States75601
    383Cancer Care Centers of South Texas - NortheastSan AntonioTexasUnited States78217
    384Texas Oncology, PA at Texas Cancer Center - ShermanShermanTexasUnited States75090
    385Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar LandTexasUnited States77479
    386Tyler Cancer CenterTylerTexasUnited States75702
    387Texas Oncology, PA - Wichita FallsWichita FallsTexasUnited States76310
    388Sandra L. Maxwell Cancer CenterCedar CityUtahUnited States84720
    389Logan Regional HospitalLoganUtahUnited States84321
    390Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurrayUtahUnited States84157
    391Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgdenUtahUnited States84403
    392Utah Valley Regional Medical Center - ProvoProvoUtahUnited States84604
    393Dixie Regional Medical Center - East CampusSaint GeorgeUtahUnited States84770
    394Utah Cancer Specialists at UCS Cancer CenterSalt Lake CityUtahUnited States84106
    395Huntsman Cancer Institute at University of UtahSalt Lake CityUtahUnited States84112
    396LDS HospitalSalt Lake CityUtahUnited States84143
    397Fletcher Allen Health Care - University Health Center CampusBurlingtonVermontUnited States05401
    398Norris Cotton Cancer Center - NorthSaint JohnsburyVermontUnited States05819
    399INOVA Alexandria HospitalAlexandriaVirginiaUnited States22304
    400Martha Jefferson Hospital Cancer Care CenterCharlottesvilleVirginiaUnited States22901
    401Danville Regional Medical CenterDanvilleVirginiaUnited States24541
    402Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolkVirginiaUnited States23507
    403Naval Medical Center - PortsmouthPortsmouthVirginiaUnited States23708-2197
    404Veterans Affairs Medical Center - RichmondRichmondVirginiaUnited States23249
    405Coastal Cancer Center at Sentara Virginia Beach General HospitalVirginia BeachVirginiaUnited States23454
    406St. Joseph Cancer CenterBellinghamWashingtonUnited States98225
    407St. Francis HospitalFederal WayWashingtonUnited States98003
    408Good Samaritan Cancer CenterPuyallupWashingtonUnited States98372
    409CCOP - Virginia Mason Research CenterSeattleWashingtonUnited States98101
    410Virginia Mason Medical CenterSeattleWashingtonUnited States98101
    411Cancer Care Northwest - Spokane SouthSpokaneWashingtonUnited States99202
    412Franciscan Cancer Center at St. Joseph Medical CenterTacomaWashingtonUnited States98405-3004
    413CCOP - NorthwestTacomaWashingtonUnited States98405
    414MultiCare Regional Cancer Center at Tacoma General HospitalTacomaWashingtonUnited States98405
    415Legacy Salmon Creek Medical CenterVancouverWashingtonUnited States98686
    416North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakimaWashingtonUnited States98902
    417West Virginia University Health Sciences Center - CharlestonCharlestonWest VirginiaUnited States25304
    418Langlade Memorial HospitalAntigoWisconsinUnited States54409
    419Fox Valley Hematology and Oncology - East Grant StreetAppletonWisconsinUnited States54911-3496
    420Theda Care Cancer InstituteAppletonWisconsinUnited States54911
    421Beloit Memorial HospitalBeloitWisconsinUnited States53511
    422Central Wisconsin Cancer Program at Agnesian HealthCareFond Du LacWisconsinUnited States54935
    423Bellin Memorial HospitalGreen BayWisconsinUnited States54301
    424St. Vincent Hospital Regional Cancer CenterGreen BayWisconsinUnited States54307-3508
    425Franciscan Skemp Healthcare - La Crosse CampusLa CrosseWisconsinUnited States54601
    426Gundersen Lutheran Center for Cancer and BloodLa CrosseWisconsinUnited States54601
    427University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadisonWisconsinUnited States53792-6164
    428Bay Area Cancer Care Center at Bay Area Medical CenterMarinetteWisconsinUnited States54143
    429Community Memorial Hospital Cancer Care CenterMenomonee FallsWisconsinUnited States53051
    430Columbia Saint Mary's Hospital - OzaukeeMequonWisconsinUnited States53097
    431Columbia-Saint Mary's Water Tower Medical CommonsMilwaukeeWisconsinUnited States53211
    432Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukeeWisconsinUnited States53215
    433Medical College of Wisconsin Cancer CenterMilwaukeeWisconsinUnited States53226
    434Veterans Affairs Medical Center - MilwaukeeMilwaukeeWisconsinUnited States53295
    435D.N. Greenwald CenterMukwonagoWisconsinUnited States53149
    436Regional Cancer Center at Oconomowoc Memorial HospitalOconomowocWisconsinUnited States53066
    437All Saints Cancer Center at Wheaton Franciscan HealthcareRacineWisconsinUnited States53405
    438Door County Cancer Center at Door County Memorial HospitalSturgeon BayWisconsinUnited States54235-1495
    439Aurora Medical CenterSummitWisconsinUnited States53066
    440Waukesha Memorial Hospital Regional Cancer CenterWaukeshaWisconsinUnited States53188
    441University of Wisconcin Cancer Center at Aspirus Wausau HospitalWausauWisconsinUnited States54401
    442West Allis Memorial HospitalWest AllisWisconsinUnited States53227
    443Riverview UW Cancer Center at Riverview HospitalWisconsin RapidsWisconsinUnited States54494
    444Rocky Mountain OncologyCasperWyomingUnited States82609
    445Tom Baker Cancer Centre - CalgaryCalgaryAlbertaCanadaT2N 4N2
    446Cross Cancer Institute at University of AlbertaEdmontonAlbertaCanadaT6G 1Z2
    447Saint John Regional HospitalSaint JohnNew BrunswickCanadaE2L 4L2
    448Doctor H. Bliss Murphy Cancer CentreSaint John'sNewfoundland and LabradorCanadaA1B 3V6
    449Margaret and Charles Juravinski Cancer CentreHamiltonOntarioCanadaL8V 5C2
    450London Regional Cancer Program at London Health Sciences CentreLondonOntarioCanadaN6A 4L6
    451Cancer Care Program at Thunder Bay Regional Health SciencesThunder BayOntarioCanadaP7B 6V4
    452Maisonneuve-Rosemont HospitalMontrealQuebecCanadaH1T 2M4
    453Hopital Notre-Dame du CHUMMontrealQuebecCanadaH2L 4M1
    454Centre Hospitalier Universitaire de QuebecQuebec CityQuebecCanadaG1R 2J6
    455CHUS-Hopital FleurimontSherbrookeQuebecCanadaJ1H 5N4
    456Allan Blair Cancer Centre at Pasqua HospitalReginaSaskatchewanCanadaS4T 7T1
    457Saskatoon Cancer Centre at the University of SaskatchewanSaskatoonSaskatchewanCanadaS7N 4H4
    458Pamela Youde Nethersole Eastern HospitalHong KongChina
    459Rabin Medical Center - Beilinson CampusPetach TikvaIsrael49100
    460Tel-Aviv Sourasky Medical CenterTel AvivIsrael64239

    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:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitlePBRT AlonePBRT + STADPLNRT + PBRT + STAD
    Arm/Group DescriptionProstate 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
    STARTED592602598
    Eligible564578574
    Eligible, Started Study Treatment, and Have Adverse Event Data547563563
    COMPLETED564578574
    NOT COMPLETED282424

    Baseline Characteristics

    Arm/Group TitlePBRT AlonePBRT + STADPLNRT + PBRT + STADTotal
    Arm/Group DescriptionProstate 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 Participants5645785741716
    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

    1. Primary Outcome
    TitlePercentage of Participants Free From Progression (FFP) at 5 Years
    DescriptionProgression 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 FrameFrom randomization to five years.

    Outcome Measure Data

    Analysis Population Description
    Eligible participants
    Arm/Group TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.001
    MethodZ 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 Hypothesisp-Value0.003
    Comments
    MethodZ-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 Hypothesisp-Value<0.001
    Comments
    MethodZ-test
    Comments
    2. Secondary Outcome
    TitlePercentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)
    DescriptionSecondary 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 FrameFrom 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 TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.57
    Confidence Interval (2-Sided) 97.5%
    0.45 to 0.72
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.67
    Confidence Interval (2-Sided) 97.5%
    0.51 to 0.89
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.39
    Confidence Interval (2-Sided) 97.5%
    0.30 to 0.51
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT Alone
    3. Secondary Outcome
    TitlePercentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)
    DescriptionHormone-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 FrameFrom 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 TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value0.137
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.73
    Confidence Interval (2-Sided) 97.5%
    0.39 to 1.39
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.007
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.39
    Confidence Interval (2-Sided) 97.5%
    0.16 to 0.95
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.29
    Confidence Interval (2-Sided) 97.5%
    0.12 to 0.68
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT Alone
    4. Secondary Outcome
    TitlePercentage of Participants With Local Failure
    DescriptionLocal 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 FrameFrom 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 TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value0.010
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.37
    Confidence Interval (2-Sided) 97.5%
    0.14 to 1.01
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.177
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.56
    Confidence Interval (2-Sided) 97.5%
    0.14 to 2.30
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.21
    Confidence Interval (2-Sided) 97.5%
    0.06 to 0.71
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT Alone
    5. Secondary Outcome
    TitlePercentage of Participants With Distant Metastasis
    DescriptionDistant 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 FrameFrom 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 TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value0.105
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.78
    Confidence Interval (2-Sided) 97.5%
    0.49 to 1.22
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.022
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.62
    Confidence Interval (2-Sided) 97.5%
    0.36 to 1.06
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.48
    Confidence Interval (2-Sided) 97.5%
    0.29 to 0.81
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT Alone
    6. Secondary Outcome
    TitlePercentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)
    DescriptionCause-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 FrameFrom 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 TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value0.137
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.71
    Confidence Interval (2-Sided) 97.5%
    0.35 to 1.43
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.141
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.68
    Confidence Interval (2-Sided) 97.5%
    0.30 to 1.54
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.014
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.47
    Confidence Interval (2-Sided) 97.5%
    0.21 to 1.03
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT Alone
    7. Secondary Outcome
    TitlePercentage of Participants Alive (Overall Mortality)
    DescriptionSurvival 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 FrameFrom 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 TitlePBRT AlonePBRT + STADPLNRT + 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 Participants564578574
    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 Hypothesisp-Value0.235
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.86
    Confidence Interval (2-Sided) 97.5%
    0.54 to 1.38
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.481
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.99
    Confidence Interval (2-Sided) 97.5%
    0.61 to 1.60
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.213
    CommentsOne-sided significance level = 0.0125
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value0.85
    Confidence Interval (2-Sided) 97.5%
    0.53 to 1.35
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT Alone
    8. Secondary Outcome
    TitlePercentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)
    DescriptionCommon 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 FrameFrom randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).

    Outcome Measure Data

    Analysis Population Description
    Eligible participants
    Arm/Group TitlePBRT AlonePBRT + STADPLNRT + PBRT + STAD
    Arm/Group DescriptionProstate 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 Participants564578574
    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 Hypothesisp-Value<0.001
    CommentsOne-sided significance level = 0.025
    MethodRegression, Logistic
    CommentsModel was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value2.47
    Confidence Interval (2-Sided) 97.5%
    1.81 to 3.37
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.007
    CommentsOne-sided significance level = 0.025
    MethodRegression, Logistic
    CommentsModel was adjusted for entry PSA level, pathology, seminal vesicle involvement, Gleason score, race, and age.
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.35
    Confidence Interval (2-Sided) 97.5%
    1.03 to 1.77
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.002
    CommentsOne-sided significance level = 0.025
    MethodRegression, Logistic
    CommentsUnivariate model was used due to the low number of events.
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value2.04
    Confidence Interval (2-Sided) 97.5%
    1.16 to 3.60
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.025
    CommentsOne-sided significance level = 0.025
    MethodRegression, Logistic
    CommentsUnivariate model was used due to the low number of events.
    Method of EstimationEstimation ParameterOdds Ratio (OR)
    Estimated Value1.47
    Confidence Interval (2-Sided) 95%
    0.975 to 2.27
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT + STAD
    9. Secondary Outcome
    TitlePercentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)
    DescriptionCommon 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 FrameAE: 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 TitlePBRT AlonePBRT + STADPLNRT + PBRT + STAD
    Arm/Group DescriptionProstate 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 Participants564578574
    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 Hypothesisp-Value0.268
    CommentsOne-sided significance level = 0.025
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.05
    Confidence Interval (2-Sided) 97.5%
    0.88 to 1.26
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.101
    CommentsOne-sided significance level = 0.025
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.10
    Confidence Interval (2-Sided) 97.5%
    0.93 to 1.32
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.119
    CommentsOne-sided significance level = 0.025
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.22
    Confidence Interval (2-Sided) 97.5%
    0.83 to 1.80
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference 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 Hypothesisp-Value0.170
    CommentsOne-sided significance level = 0.025
    MethodLog Rank
    Comments
    Method of EstimationEstimation ParameterHazard Ratio (HR)
    Estimated Value1.16
    Confidence Interval (2-Sided) 97.5%
    0.82 to 1.65
    Parameter Dispersion Type:
    Value:
    Estimation CommentsReference level = PBRT + STAD
    10. Secondary Outcome
    TitleComparison 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 FrameFrom 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
    11. Secondary Outcome
    TitleAssessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25)
    Description
    Time FrameFrom 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
    12. Secondary Outcome
    TitleAssessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY)
    Description
    Time FrameFrom 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
    13. Secondary Outcome
    TitleEvaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D)
    Description
    Time FrameFrom 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
    14. Secondary Outcome
    TitlePrognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints
    Description
    Time FrameDate 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
    15. Secondary Outcome
    TitleAssessment 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 FrameFrom 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 FrameWeekly 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 TitlePBRT AlonePBRT + STADTPLNRT + PBRT + STADT
    Arm/Group DescriptionProstate 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 AlonePBRT + STADTPLNRT + PBRT + STADT
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total48/547 (8.8%) 43/563 (7.6%) 43/563 (7.6%)
    Serious Adverse Events
    PBRT AlonePBRT + STADTPLNRT + PBRT + STADT
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total18/547 (3.3%) 29/563 (5.2%) 23/563 (4.1%)
    Blood and lymphatic system disorders
    Blood disorder0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Cardiac disorders
    Cardiac disorder0/547 (0%) 1/563 (0.2%) 1/563 (0.2%)
    Left ventricular failure0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Myocardial ischemia1/547 (0.2%) 2/563 (0.4%) 0/563 (0%)
    Pericarditis0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Ventricular tachycardia0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Eye disorders
    Eye disorder0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Gastrointestinal disorders
    Abdominal pain0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Anal pain0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Colonic obstruction0/547 (0%) 0/563 (0%) 2/563 (0.4%)
    Diarrhea1/547 (0.2%) 2/563 (0.4%) 1/563 (0.2%)
    Esophageal hemorrhage0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Esophageal mucositis1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Esophagitis1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Ileus1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Pancreatitis0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Proctitis0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Rectal hemorrhage1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Small intestinal obstruction0/547 (0%) 1/563 (0.2%) 1/563 (0.2%)
    General disorders
    Fatigue2/547 (0.4%) 0/563 (0%) 0/563 (0%)
    Hepatobiliary disorders
    Cholecystitis0/547 (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 complications1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Investigations
    Alanine aminotransferase increased0/547 (0%) 2/563 (0.4%) 2/563 (0.4%)
    Aspartate aminotransferase increased0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Metabolism and nutrition disorders
    Dehydration0/547 (0%) 2/563 (0.4%) 0/563 (0%)
    Hyperglycemia0/547 (0%) 1/563 (0.2%) 1/563 (0.2%)
    Musculoskeletal and connective tissue disorders
    Bone pain1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Joint pain0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Treatment related secondary malignancy0/547 (0%) 2/563 (0.4%) 0/563 (0%)
    Nervous system disorders
    Ischemia cerebrovascular1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Syncope vasovagal0/547 (0%) 0/563 (0%) 1/563 (0.2%)
    Renal and urinary disorders
    Bladder hemorrhage1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Bladder obstruction1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Bladder stenosis1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Cystitis2/547 (0.4%) 4/563 (0.7%) 3/563 (0.5%)
    Hemorrhage urinary tract0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Renal hemorrhage1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Ureteric obstruction0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Urethral obstruction0/547 (0%) 2/563 (0.4%) 0/563 (0%)
    Urethral stricture1/547 (0.2%) 0/563 (0%) 0/563 (0%)
    Urinary frequency1/547 (0.2%) 3/563 (0.5%) 2/563 (0.4%)
    Urinary incontinence4/547 (0.7%) 1/563 (0.2%) 2/563 (0.4%)
    Urinary retention1/547 (0.2%) 1/563 (0.2%) 1/563 (0.2%)
    Urogenital disorder5/547 (0.9%) 2/563 (0.4%) 1/563 (0.2%)
    Reproductive system and breast disorders
    Erectile dysfunction1/547 (0.2%) 1/563 (0.2%) 0/563 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Pleural effusion0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Respiratory disorder0/547 (0%) 1/563 (0.2%) 1/563 (0.2%)
    Skin and subcutaneous tissue disorders
    Skin disorder0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Vascular disorders
    Hot flashes0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Lymphocele0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Thrombosis0/547 (0%) 1/563 (0.2%) 0/563 (0%)
    Other (Not Including Serious) Adverse Events
    PBRT AlonePBRT + STADTPLNRT + PBRT + STADT
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total433/547 (79.2%) 492/563 (87.4%) 509/563 (90.4%)
    Blood and lymphatic system disorders
    Hemoglobin decreased32/547 (5.9%) 73/563 (13%) 80/563 (14.2%)
    Gastrointestinal disorders
    Constipation54/547 (9.9%) 53/563 (9.4%) 59/563 (10.5%)
    Diarrhea110/547 (20.1%) 127/563 (22.6%) 219/563 (38.9%)
    Gastrointestinal disorder36/547 (6.6%) 36/563 (6.4%) 33/563 (5.9%)
    Hemorrhoids26/547 (4.8%) 29/563 (5.2%) 33/563 (5.9%)
    Proctitis62/547 (11.3%) 55/563 (9.8%) 66/563 (11.7%)
    Rectal hemorrhage43/547 (7.9%) 50/563 (8.9%) 48/563 (8.5%)
    General disorders
    Fatigue148/547 (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 increased8/547 (1.5%) 35/563 (6.2%) 23/563 (4.1%)
    Aspartate aminotransferase increased11/547 (2%) 35/563 (6.2%) 20/563 (3.6%)
    Leukopenia32/547 (5.9%) 29/563 (5.2%) 40/563 (7.1%)
    Lymphopenia28/547 (5.1%) 26/563 (4.6%) 50/563 (8.9%)
    Musculoskeletal and connective tissue disorders
    Back pain30/547 (5.5%) 35/563 (6.2%) 26/563 (4.6%)
    Psychiatric disorders
    Libido decreased35/547 (6.4%) 67/563 (11.9%) 83/563 (14.7%)
    Renal and urinary disorders
    Cystitis69/547 (12.6%) 72/563 (12.8%) 71/563 (12.6%)
    Hemorrhage urinary tract36/547 (6.6%) 29/563 (5.2%) 36/563 (6.4%)
    Urinary frequency281/547 (51.4%) 333/563 (59.1%) 348/563 (61.8%)
    Urinary incontinence237/547 (43.3%) 215/563 (38.2%) 239/563 (42.5%)
    Urinary retention69/547 (12.6%) 69/563 (12.3%) 78/563 (13.9%)
    Urogenital disorder77/547 (14.1%) 64/563 (11.4%) 80/563 (14.2%)
    Reproductive system and breast disorders
    Erectile dysfunction155/547 (28.3%) 185/563 (32.9%) 202/563 (35.9%)
    Vascular disorders
    Hot flashes36/547 (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/TitleWendy Seiferheld
    OrganizationNRG Oncology
    Phone215-574-3208
    Emailseiferheldw@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:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022