Hypofractionated Radiation Therapy or Conventional Radiation Therapy After Surgery in Treating Patients With Prostate Cancer
Sponsor
NRG Oncology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03274687
Collaborator
National Cancer Institute (NCI) (NIH)
296
241
2
111.1
1.2
0
Study Details
Study Description
Brief Summary
This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVES:
- To demonstrate that hypofractionated post-prostatectomy radiotherapy (HYPORT) does not increase patient-reported gastrointestinal (GI) or genitourinary (GU) symptoms over conventionally fractionated post-prostatectomy (COPORT) at the 2-year time point.
SECONDARY OBJECTIVES:
-
To compare patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)-26 at end of radiation therapy (RT) and 6, 12, 24, and 60 months from end of treatment.
-
To compare patient-reported GU symptoms using the EPIC-26 at end of RT and 6, 12, 24, and 60 months from end of treatment.
-
To compare the cost effectiveness based on the cost of radiotherapy and measured utilities for health outcomes using the EuroQol five dimensions questionnaire (EQ-5D).
-
To compare time to progression (TTP) where progression is defined as the first occurrence of biochemical failure (BF), local failure, regional failure, distant metastasis (DM), institution of new unplanned anticancer treatment, or death from prostate cancer (prostate cancer specific mortality [PCSM]).
-
To compare freedom from biochemical failure (FFBF) and TTP rates with an alternate prostate specific antigen (PSA) >= PSA nadir + 2 ng/mL definition of BF.
-
To compare local failure, regional failure, salvage therapy (i.e. institution of new unplanned anticancer treatment), DM, PCSM, and overall survival (OS) rates.
-
Assessment of adverse events. VIII. Paraffin-embedded tissue block, serum, plasma, whole blood, and urine for future translational research analyses for predictors of toxicity following hypofractionated or conventionally fractionated post-prostatectomy radiotherapy.
After completion of study treatment, patients are followed up every 6 months for 2 years and every year for 3 years and thereafter.
Study Design
Study Type:
Interventional
Actual Enrollment
:
296 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of Hypofractionated Post-prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-prostatectomy Radiation Therapy (COPORT)
Actual Study Start Date
:
Jul 28, 2017
Actual Primary Completion Date
:
Dec 1, 2020
Anticipated Study Completion Date
:
Nov 1, 2026
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Conventional radiation therapy Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. |
Radiation: Conventional radiation therapy
62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
Drug: Optional androgen deprivation therapy
Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Other Names:
|
| Experimental: Hypofractionated radiation therapy Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. |
Radiation: Hypofractionated radiation therapy
66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity.
Other Names:
Drug: Optional androgen deprivation therapy
Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years [Baseline (randomization), 2 years]
The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.
- Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years [Baseline, 2 years]
The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The bowel domain contains 14 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.
Secondary Outcome Measures
- Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years [Baseline, end of RT, then 6 months,1 and 5 years from the start of RT (5 year time point has not yet been reached). RT dates depend on timing and duration of androgen deprivation therapy (ADT) (optional) and RT.]
The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.
- Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years [Baseline, end of RT, then 6 months,1 and 5 years from the start of RT (5 year time point has not yet been reached). RT dates depend on timing and duration of ADT (optional) and RT.]
The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The bowel domain contains 14 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL.
- Percentage of Participants With Biochemical Failure [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years.]
Biochemical failure was analyzed using two different definitions. The protocol definition of biochemical failure is a PSA measurement ≥ 0.4 ng/mL and rising (i.e. PSA ≥ 0.4 ng/mL followed by a value higher than the first by any amount) or followed by initiation of salvage hormones. The Phoenix definition of biochemical failure is a PSA measurement ≥ PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value. Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
- Percentage of Participants With Progression [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Progression (failure) is defined as the first occurrence of biochemical failure, local failure, regional failure, distant failure, institution of new unplanned anticancer treatment, or death from prostate cancer. Time to progression is defined as time from randomization to the date of progression, last known follow-up (censored), or death without progression (competing risk). Progression rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
- Percentage of Participants With Local-Regional Failure [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Local-regional failure is defined as local or regional failure. Local failure is defined as the development of a new biopsy-proven mass in the prostate bed. Regional failure is defined as radiographic evidence (CT or MRI) of lymphadenopathy (lymph node size ≥ 1.0 cm in the short axis) in a patient without the diagnosis of a hematologic/lymphomatous disorder associated with adenopathy. Time to local-regional failure is defined as time from randomization to the date of first local-regional failure, last known follow-up (censored), or death without local-regional (competing risk). Local-regional failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
- Percentage of Participants Receiving Salvage Therapy [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Salvage therapy is defined as the initiation of new unplanned anticancer treatment. Time to salvage therapy initiation is defined as time from randomization to the date of first salvage therapy, last known follow-up (censored), or death without salvage therapy (competing risk). Salvage therapy rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage initiation times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
- Percentage of Participants With Distant Metastasis [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk). Distant metastasis rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided.
- Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality) [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Cause of death was centrally reviewed. Count and percentage at time of analysis are reported.
- Percent of Participants Alive (Overall Survival) [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 2-year rates are provided.
- Number of Participants With Grade 3+ Adverse Events [From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly.]
Common Terminology Criteria for Adverse Events (CTCAE) version 4 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. Counts of participants with any grade 3 or higher adverse event, any grade 3 or higher gastrointestinal adverse events, and any grade 3 or higher genitourinary adverse events are reported. Adverse events of any attribution are included.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
PRIOR TO STEP 1 REGISTRATION
-
Adenocarcinoma of the prostate treated primarily with radical prostatectomy
-
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
-
One of the following pathologic T-classifications: pT2 or pT3
-
Patients with positive surgical margins are eligible
-
One of the following pathologic N-classifications: pN0, pNX
-
If a lymph node dissection is performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator versus (vs.) extended lymph node dissection) should be noted whenever possible
-
No clinical evidence of regional lymph node metastasis
-
Computed tomography (CT) (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast), magnetic resonance imaging (MRI), nodal sampling, or dissection of the pelvis within 120 days prior to step 1 registration
-
Patients with pelvic lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1 cm in the short axis
-
A post-radical prostatectomy study entry PSA >= 45 days after prostatectomy and within 30 days prior to step 1, < 2.0 ng/mL
-
No evidence of a local recurrence in the prostate fossa based on a digital rectal examination (DRE) within 60 days prior to step 1 registration
-
Patients with equivocal or questionable DRE findings should have an MRI of the pelvis to exclude the presence of a prostate fossa mass
-
Patients with equivocal or questionable exam findings by DRE or MRI are eligible if a biopsy of the lesion is negative for tumor
-
No evidence of bone metastases (M0) on bone scan (Na F positron emission tomography (PET)/CT is an acceptable substitute) within 120 days prior to step 1 registration
-
Equivocal bone scan findings are allowed if plain films and/or MRI are negative for metastasis
-
Zubrod performance status 0-1 within 60 days prior to step 1 registration
-
The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration
-
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire
-
Only English and French-speaking patients are eligible to participate
-
PRIOR TO STEP 2 REGISTRATION
-
The EPIC-26 must be completed in full and entered within 10 business days after step 1 registration; NRG Oncology Statistical and Data Management Center has 3 business days to score the results and send a notification to the site to proceed to step 2 randomization
Exclusion Criteria:
-
A post-prostatectomy PSA nadir >= 0.2 ng/mL AND Gleason >= 7
-
pT2 with a negative surgical margin and PSA < 0.1 ng/mL
-
Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration;
-
Note: The use of finasteride or dutasteride (? tamsulosin) for longer periods prior to prostatectomy is acceptable
-
Androgen deprivation therapy started after prostatectomy and prior to step 1 registration for > 6 weeks (42 days)
-
Neoadjuvant chemotherapy before or after prostatectomy
-
Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years and not in the pelvis; (for example, carcinoma in situ of the oral cavity is permissible if disease free for a minimum of 3 years; however, patients with prior history of bladder cancer are not allowed no matter the disease free duration); prior hematological (e.g., leukemia, lymphoma, myeloma) malignancy is not allowed
-
Previous chemotherapy for any other disease site if given within 3 years prior to step 1
-
Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy treatment volumes
-
Severe, active co-morbidity, defined as follows:
-
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 step 1 registration
-
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration
-
Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease
-
Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
-
End-stage renal disease (ie, on dialysis or dialysis has been recommended)
-
Prior allergic reaction to the study drugs involved in this protocol
-
History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | United States | 35233 |
| 2 | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | United States | 36688 |
| 3 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 4 | Marin Cancer Care Inc | Greenbrae | California | United States | 94904 |
| 5 | Marin General Hospital | Greenbrae | California | United States | 94904 |
| 6 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 7 | Los Angeles County-USC Medical Center | Los Angeles | California | United States | 90033 |
| 8 | USC / Norris Comprehensive Cancer Center | Los Angeles | California | United States | 90033 |
| 9 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 10 | Fremont - Rideout Cancer Center | Marysville | California | United States | 95901 |
| 11 | Kaiser Permanente Oakland-Broadway | Oakland | California | United States | 94611 |
| 12 | Stanford Cancer Institute Palo Alto | Palo Alto | California | United States | 94304 |
| 13 | Pomona Valley Hospital Medical Center | Pomona | California | United States | 91767 |
| 14 | Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | United States | 95670 |
| 15 | Rohnert Park Cancer Center | Rohnert Park | California | United States | 94928 |
| 16 | The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | United States | 95678 |
| 17 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 18 | South Sacramento Cancer Center | Sacramento | California | United States | 95823 |
| 19 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051 |
| 20 | Kaiser Permanente Cancer Treatment Center | South San Francisco | California | United States | 94080 |
| 21 | Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | United States | 96161 |
| 22 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 23 | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | United States | 80907 |
| 24 | UCHealth Memorial Hospital Central | Colorado Springs | Colorado | United States | 80909 |
| 25 | Yale University | New Haven | Connecticut | United States | 06520 |
| 26 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 27 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 28 | Beebe Health Campus | Rehoboth Beach | Delaware | United States | 19971 |
| 29 | TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware | United States | 19973 |
| 30 | UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | United States | 33146 |
| 31 | UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | United States | 33442 |
| 32 | Mayo Clinic in Florida | Jacksonville | Florida | United States | 32224-9980 |
| 33 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 34 | Cleveland Clinic-Weston | Weston | Florida | United States | 33331 |
| 35 | Grady Health System | Atlanta | Georgia | United States | 30303 |
| 36 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 37 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 38 | Emory Saint Joseph's Hospital | Atlanta | Georgia | United States | 30342 |
| 39 | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | United States | 31405 |
| 40 | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 41 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 42 | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | United States | 96817 |
| 43 | SIH Cancer Institute | Carterville | Illinois | United States | 62918 |
| 44 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 45 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 46 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 47 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 48 | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | United States | 60451 |
| 49 | OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | United States | 61615 |
| 50 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 51 | SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois | United States | 61114 |
| 52 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 53 | Goshen Center for Cancer Care | Goshen | Indiana | United States | 46526 |
| 54 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 55 | Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 56 | University of Kansas Cancer Center | Kansas City | Kansas | United States | 66160 |
| 57 | Olathe Health Cancer Center | Olathe | Kansas | United States | 66061 |
| 58 | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | United States | 66210 |
| 59 | Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas | United States | 66606 |
| 60 | Ascension Via Christi Hospitals Wichita | Wichita | Kansas | United States | 67214 |
| 61 | Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | United States | 42303 |
| 62 | East Jefferson General Hospital | Metairie | Louisiana | United States | 70006 |
| 63 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 64 | Maine Medical Center-Bramhall Campus | Portland | Maine | United States | 04102 |
| 65 | Maine Medical Center- Scarborough Campus | Scarborough | Maine | United States | 04074 |
| 66 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
| 67 | Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | United States | 21044 |
| 68 | University of Maryland Radiation Oncology Center at Union Hospital | Elkton | Maryland | United States | 21921 |
| 69 | UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland | United States | 21061 |
| 70 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 71 | Lowell General Hospital | Lowell | Massachusetts | United States | 01854 |
| 72 | Beth Israel Deaconess Hospital-Plymouth | Plymouth | Massachusetts | United States | 02360 |
| 73 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 74 | Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | United States | 48183 |
| 75 | 21st Century Oncology MHP - Clarkston | Clarkston | Michigan | United States | 48346 |
| 76 | McLaren Cancer Institute-Clarkston | Clarkston | Michigan | United States | 48346 |
| 77 | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | United States | 48038 |
| 78 | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 79 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 80 | 21st Century Oncology MHP - Farmington | Farmington Hills | Michigan | United States | 48334 |
| 81 | Weisberg Cancer Treatment Center | Farmington Hills | Michigan | United States | 48334 |
| 82 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 83 | McLaren Cancer Institute-Flint | Flint | Michigan | United States | 48532 |
| 84 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 85 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 86 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 87 | McLaren-Greater Lansing | Lansing | Michigan | United States | 48910 |
| 88 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
| 89 | McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | United States | 48446 |
| 90 | Saint Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 91 | McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | United States | 48043 |
| 92 | McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | United States | 48858 |
| 93 | McLaren Cancer Institute-Owosso | Owosso | Michigan | United States | 48867 |
| 94 | McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | United States | 49770 |
| 95 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
| 96 | McLaren-Port Huron | Port Huron | Michigan | United States | 48060 |
| 97 | 21st Century Oncology MHP - Troy | Troy | Michigan | United States | 48098 |
| 98 | Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | United States | 48322 |
| 99 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 100 | Saint Luke's Hospital of Duluth | Duluth | Minnesota | United States | 55805 |
| 101 | Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | United States | 56001 |
| 102 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
| 103 | Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | United States | 56303 |
| 104 | Southeast Cancer Center | Cape Girardeau | Missouri | United States | 63703 |
| 105 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 106 | North Kansas City Hospital | Kansas City | Missouri | United States | 64116 |
| 107 | Kansas City Veterans Affairs Medical Center | Kansas City | Missouri | United States | 64128 |
| 108 | The University of Kansas Cancer Center-South | Kansas City | Missouri | United States | 64131 |
| 109 | University of Kansas Cancer Center - North | Kansas City | Missouri | United States | 64154 |
| 110 | University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | United States | 64064 |
| 111 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64506 |
| 112 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 113 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 114 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 115 | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri | United States | 63376 |
| 116 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 117 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
| 118 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 119 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 120 | Wentworth-Douglass Hospital | Dover | New Hampshire | United States | 03820 |
| 121 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 122 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 123 | Lovelace Radiation Oncology | Albuquerque | New Mexico | United States | 87109 |
| 124 | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | United States | 87109 |
| 125 | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | United States | 88011 |
| 126 | Northwell Health Imbert Cancer Center | Bay Shore | New York | United States | 11706 |
| 127 | New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | United States | 11215 |
| 128 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 129 | Mary Imogene Bassett Hospital | Cooperstown | New York | United States | 13326 |
| 130 | Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | United States | 14905 |
| 131 | Northwell Health/Center for Advanced Medicine | Lake Success | New York | United States | 11042 |
| 132 | NYP/Weill Cornell Medical Center | New York | New York | United States | 10065 |
| 133 | Dickstein Cancer Treatment Center | White Plains | New York | United States | 10601 |
| 134 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 135 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
| 136 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 137 | Rex Cancer Center | Raleigh | North Carolina | United States | 27607 |
| 138 | NHRMC Radiation Oncology - Supply | Supply | North Carolina | United States | 28462 |
| 139 | NHRMC Radiation Oncology - 16th Street | Wilmington | North Carolina | United States | 28401 |
| 140 | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
| 141 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
| 142 | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | United States | 44122 |
| 143 | Geauga Hospital | Chardon | Ohio | United States | 44024 |
| 144 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 145 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 146 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 147 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 148 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
| 149 | Mercy Cancer Center-Elyria | Elyria | Ohio | United States | 44035 |
| 150 | Cleveland Clinic Cancer Center Independence | Independence | Ohio | United States | 44131 |
| 151 | Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | United States | 44906 |
| 152 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 153 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 154 | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | United States | 44130 |
| 155 | University Hospitals Parma Medical Center | Parma | Ohio | United States | 44129 |
| 156 | North Coast Cancer Care | Sandusky | Ohio | United States | 44870 |
| 157 | UH Seidman Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | United States | 44870 |
| 158 | Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | United States | 44136 |
| 159 | ProMedica Flower Hospital | Sylvania | Ohio | United States | 43560 |
| 160 | UHHS-Westlake Medical Center | Westlake | Ohio | United States | 44145 |
| 161 | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | United States | 44691 |
| 162 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 163 | Abington Memorial Hospital | Abington | Pennsylvania | United States | 19001 |
| 164 | Crozer-Keystone Regional Cancer Center at Broomall | Broomall | Pennsylvania | United States | 19008 |
| 165 | Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | United States | 19317 |
| 166 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 167 | Northeast Radiation Oncology Center | Dunmore | Pennsylvania | United States | 18512 |
| 168 | Crozer Regional Cancer Center at Brinton Lake | Glen Mills | Pennsylvania | United States | 19342 |
| 169 | UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | United States | 17109 |
| 170 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 171 | Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | United States | 18840 |
| 172 | Reading Hospital | West Reading | Pennsylvania | United States | 19611 |
| 173 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 174 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
| 175 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 176 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 177 | Saint Francis Cancer Center | Greenville | South Carolina | United States | 29607 |
| 178 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 179 | Self Regional Healthcare | Greenwood | South Carolina | United States | 29646 |
| 180 | Gibbs Cancer Center-Pelham | Greer | South Carolina | United States | 29651 |
| 181 | The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island | South Carolina | United States | 29926 |
| 182 | Carolina Regional Cancer Center | Myrtle Beach | South Carolina | United States | 29577 |
| 183 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
| 184 | Spartanburg Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 185 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 186 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 187 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 188 | UTMB Cancer Center at Victory Lakes | League City | Texas | United States | 77573 |
| 189 | American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah | United States | 84003 |
| 190 | Farmington Health Center | Farmington | Utah | United States | 84025 |
| 191 | Logan Regional Hospital | Logan | Utah | United States | 84321 |
| 192 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
| 193 | McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 194 | Ogden Regional Medical Center | Ogden | Utah | United States | 84405 |
| 195 | Utah Valley Regional Medical Center | Provo | Utah | United States | 84604 |
| 196 | Riverton Hospital | Riverton | Utah | United States | 84065 |
| 197 | Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah | United States | 84106 |
| 198 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 199 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 200 | South Jordan Health Center | South Jordan | Utah | United States | 84009 |
| 201 | Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | United States | 05819 |
| 202 | Augusta Health Center for Cancer and Blood Disorders | Fishersville | Virginia | United States | 22939 |
| 203 | Naval Medical Center - Portsmouth | Portsmouth | Virginia | United States | 23708-2197 |
| 204 | Overlake Medical Center | Bellevue | Washington | United States | 98004 |
| 205 | Ascension Saint Elizabeth Hospital | Appleton | Wisconsin | United States | 54915 |
| 206 | Ascension Southeast Wisconsin Hospital - Elmbrook Campus | Brookfield | Wisconsin | United States | 53045 |
| 207 | Mayo Clinic Health System Eau Claire Hospital-Luther Campus | Eau Claire | Wisconsin | United States | 54703 |
| 208 | Ascension Saint Francis - Reiman Cancer Center | Franklin | Wisconsin | United States | 53132 |
| 209 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 210 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 211 | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | United States | 53142 |
| 212 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 213 | Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | United States | 54601 |
| 214 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 215 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | United States | 54143 |
| 216 | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | United States | 53051 |
| 217 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 218 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 219 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 220 | Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | United States | 53295 |
| 221 | Ascension Mercy Hospital | Oshkosh | Wisconsin | United States | 54904 |
| 222 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 223 | Ascension All Saints Hospital | Racine | Wisconsin | United States | 53405 |
| 224 | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | United States | 53081 |
| 225 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 226 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 227 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 228 | Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | United States | 53095 |
| 229 | Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | United States | 54494 |
| 230 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 231 | Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8V 5C2 |
| 232 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
| 233 | Centre De Sante Et De Services Sociaux De Chicoutimi | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 234 | CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada | H1T 2M4 |
| 235 | CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2X 3E4 |
| 236 | The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec | Canada | H3H 2R9 |
| 237 | CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Quebec City | Quebec | Canada | G1R 2J6 |
| 238 | Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 239 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 240 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 241 | Kantonsspital Aarau | Aarau | Switzerland | 5001 |
Sponsors and Collaborators
- NRG Oncology
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Mark Buyyounouski, NRG Oncology
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
NRG Oncology
ClinicalTrials.gov Identifier:
NCT03274687
Other Study ID Numbers:
- NRG-GU003
- NCI-2016-01771
- NRG-GU003
- NRG-GU003
- NRG-GU003
- U10CA180868
First Posted:
Sep 7, 2017
Last Update Posted:
Jun 28, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Of 298 screened, 296 participants were randomized. |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy (ADT): Any luteinizing hormone-releasing hormone (LHRH) agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Period Title: Overall Study | ||
| STARTED | 152 | 144 |
| Eligible | 151 | 143 |
| Eligible With Adverse Event Data | 148 | 141 |
| COMPLETED | 151 | 143 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy | Total |
|---|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Total of all reporting groups |
| Overall Participants | 151 | 143 | 294 |
| Age, Customized (Count of Participants) | |||
| ≤ 49 years |
3
2%
|
2
1.4%
|
5
1.7%
|
| 50 - 59 years |
27
17.9%
|
31
21.7%
|
58
19.7%
|
| 60 - 69 years |
74
49%
|
83
58%
|
157
53.4%
|
| ≥ 70 years |
47
31.1%
|
27
18.9%
|
74
25.2%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
151
100%
|
143
100%
|
294
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
7
4.6%
|
5
3.5%
|
12
4.1%
|
| Not Hispanic or Latino |
142
94%
|
136
95.1%
|
278
94.6%
|
| Unknown or Not Reported |
2
1.3%
|
2
1.4%
|
4
1.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
1.3%
|
5
3.5%
|
7
2.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
22
14.6%
|
21
14.7%
|
43
14.6%
|
| White |
125
82.8%
|
114
79.7%
|
239
81.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
1.3%
|
3
2.1%
|
5
1.7%
|
| EPIC Group (Count of Participants) | |||
| A Score Group (bowel domain score > 96, urinary domain score > 84) |
56
37.1%
|
52
36.4%
|
108
36.7%
|
| B Score Group (bowel domain score > 96, urinary domain score ≤ 84) |
29
19.2%
|
32
22.4%
|
61
20.7%
|
| C Score Group (bowel domain score ≤ 96, urinary domain score > 84) |
31
20.5%
|
31
21.7%
|
62
21.1%
|
| D Score Group (bowel domain score ≤ 96, urinary domain score ≤ 84) |
35
23.2%
|
28
19.6%
|
63
21.4%
|
| Prior androgen deprivation therapy (ADT) (Count of Participants) | |||
| No |
118
78.1%
|
110
76.9%
|
228
77.6%
|
| Yes |
33
21.9%
|
33
23.1%
|
66
22.4%
|
| Prostate-specific antigen (PSA) ng/mL (Count of Participants) | |||
| 0.0 - 0.5 |
135
89.4%
|
128
89.5%
|
263
89.5%
|
| 0.6 - 1.0 |
10
6.6%
|
14
9.8%
|
24
8.2%
|
| 1.1 - 1.5 |
3
2%
|
1
0.7%
|
4
1.4%
|
| 1.6 - 2.0 |
3
2%
|
0
0%
|
3
1%
|
| Gleason score (Count of Participants) | |||
| 6 |
16
10.6%
|
7
4.9%
|
23
7.8%
|
| 7 |
105
69.5%
|
109
76.2%
|
214
72.8%
|
| 8 |
14
9.3%
|
15
10.5%
|
29
9.9%
|
| 9 |
15
9.9%
|
11
7.7%
|
26
8.8%
|
| 10 |
1
0.7%
|
1
0.7%
|
2
0.7%
|
| T-Stage (Count of Participants) | |||
| T2 |
76
50.3%
|
60
42%
|
136
46.3%
|
| T3 |
75
49.7%
|
83
58%
|
158
53.7%
|
| N-Stage (Count of Participants) | |||
| NX |
30
19.9%
|
33
23.1%
|
63
21.4%
|
| N0 |
121
80.1%
|
110
76.9%
|
231
78.6%
|
| Zubrod (Count of Participants) | |||
| 0 |
128
84.8%
|
127
88.8%
|
255
86.7%
|
| 1 |
23
15.2%
|
16
11.2%
|
39
13.3%
|
Outcome Measures
| Title | Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years |
|---|---|
| Description | The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL. |
| Time Frame | Baseline (randomization), 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants with baseline and two-year data |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 127 | 117 |
| Mean (Standard Deviation) [units on a scale] |
-4.12
(14.72)
|
-5.06
(15.16)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 < -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 90% power for this endpoint and 91% power for the bowel endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -5. | |
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years |
|---|---|
| Description | The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The bowel domain contains 14 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL. |
| Time Frame | Baseline, 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants with baseline and two-year data |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 127 | 117 |
| Mean (Standard Error) [units on a scale] |
-1.42
(8.35)
|
-4.21
(11.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Null hypothesis (H0): mean change score of HYPORT (∆2) is worse than that of COPORT (∆1), specifically ∆2 - ∆1 < -5. Alternative hypothesis (HA): ∆2 is not worse than ∆1, specifically ∆2 - ∆1 ≥ -5. The study sample size is based on 91% power for this endpoint and 90% power for the urinary endpoint (resulting in 81.9% statistical power to reject the null hypothesis for both endpoints) and a one-sided alpha=0.025 with an overall type I error of 0.05 with a Bonferroni adjustment. | |
| Type of Statistical Test | Non-Inferiority | |
| Comments | The non-inferiority margin for the difference in mean change score (∆2 - ∆1) is -6. | |
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | ||
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 Years |
|---|---|
| Description | The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The urinary domain contains 12 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL. |
| Time Frame | Baseline, end of RT, then 6 months,1 and 5 years from the start of RT (5 year time point has not yet been reached). RT dates depend on timing and duration of androgen deprivation therapy (ADT) (optional) and RT. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants with baseline data |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| End of RT |
-4.34
(22.61)
|
-7.90
(20.93)
|
| 6 months |
0.08
(20.26)
|
-1.71
(18.55)
|
| 1 year |
-2.32
(22.63)
|
-5.41
(21.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | End of RT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.70 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | 6 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.67 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | 1 year | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.66 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 Years |
|---|---|
| Description | The EPIC is a prostate cancer health-related quality of life (HRQOL) self-administered instrument measuring patient-reported urinary, bowel, sexual, and hormonal symptoms related to prostate cancer treatments. Response options for each item form a Likert scale with scores transformed linearly to a 0-100 scale. Domain scores are also on a 0-100 scale with higher scores representing better HRQOL. The bowel domain contains 14 items. Change from baseline is calculated by subtracting baseline from later score, with a positive change score indicating increased HRQOL. |
| Time Frame | Baseline, end of RT, then 6 months,1 and 5 years from the start of RT (5 year time point has not yet been reached). RT dates depend on timing and duration of ADT (optional) and RT. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants with baseline data |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| End of RT |
-6.83
(15.82)
|
-14.96
(21.32)
|
| 6 months |
-1.90
(13.63)
|
-2.70
(13.98)
|
| 1 year |
-2.67
(12.65)
|
-3.11
(13.93)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | End of RT | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0011 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | 6 months | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.93 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | 1 year | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.30 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Percentage of Participants With Biochemical Failure |
|---|---|
| Description | Biochemical failure was analyzed using two different definitions. The protocol definition of biochemical failure is a PSA measurement ≥ 0.4 ng/mL and rising (i.e. PSA ≥ 0.4 ng/mL followed by a value higher than the first by any amount) or followed by initiation of salvage hormones. The Phoenix definition of biochemical failure is a PSA measurement ≥ PSA nadir + 2 ng/mL where nadir is the lowest post-RT PSA value. Time to biochemical failure is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Protocol definition |
8.3
5.5%
|
11.8
8.3%
|
| Phoenix definition |
3.5
2.3%
|
8.0
5.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Protocol definition of biochemical failure | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.29 |
| Comments | ||
| Method | Gray's test | |
| Comments | Two-sided significance level 0.05 | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Phoenix definition of biochemical failure | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | Gray's test | |
| Comments | Two-sided significance level 0.05 | |
| Title | Percentage of Participants With Progression |
|---|---|
| Description | Progression (failure) is defined as the first occurrence of biochemical failure, local failure, regional failure, distant failure, institution of new unplanned anticancer treatment, or death from prostate cancer. Time to progression is defined as time from randomization to the date of progression, last known follow-up (censored), or death without progression (competing risk). Progression rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Number (95% Confidence Interval) [percentage of participants] |
14.4
9.5%
|
14.7
10.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.96 |
| Comments | Two-sided significance level 0.05 | |
| Method | Gray's test | |
| Comments | ||
| Title | Percentage of Participants With Local-Regional Failure |
|---|---|
| Description | Local-regional failure is defined as local or regional failure. Local failure is defined as the development of a new biopsy-proven mass in the prostate bed. Regional failure is defined as radiographic evidence (CT or MRI) of lymphadenopathy (lymph node size ≥ 1.0 cm in the short axis) in a patient without the diagnosis of a hematologic/lymphomatous disorder associated with adenopathy. Time to local-regional failure is defined as time from randomization to the date of first local-regional failure, last known follow-up (censored), or death without local-regional (competing risk). Local-regional failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Number (95% Confidence Interval) [percentage of participants] |
0.7
0.5%
|
0.8
0.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | Two-sided significance level 0.05 | |
| Method | Gray's test | |
| Comments | ||
| Title | Percentage of Participants Receiving Salvage Therapy |
|---|---|
| Description | Salvage therapy is defined as the initiation of new unplanned anticancer treatment. Time to salvage therapy initiation is defined as time from randomization to the date of first salvage therapy, last known follow-up (censored), or death without salvage therapy (competing risk). Salvage therapy rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of salvage initiation times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Number (95% Confidence Interval) [percentage of participants] |
7.5
5%
|
5.8
4.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.41 |
| Comments | Two-sided significance level 0.05 | |
| Method | Gray's test | |
| Comments | ||
| Title | Percentage of Participants With Distant Metastasis |
|---|---|
| Description | Distant metastasis (failure) is defined as radiographic evidence of hematogenous spread evaluated by bone scan, CT, or MRI. Time to distant metastasis is defined as time from randomization to the date of first distant metastasis, last known follow-up (censored), or death without local recurrence (competing risk). Distant metastasis rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year rates are provided. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Number (95% Confidence Interval) [percentage of participants] |
0.7
0.5%
|
2.2
1.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | Two-sided significance level 0.05 | |
| Method | Gray's test | |
| Comments | ||
| Title | Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality) |
|---|---|
| Description | Cause of death was centrally reviewed. Count and percentage at time of analysis are reported. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Percent of Participants Alive (Overall Survival) |
|---|---|
| Description | Overall survival time is defined as time from registration/randomization to the date of death (failure) from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. 2-year rates are provided. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Two-year rates reported here. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible participants |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 151 | 143 |
| Number (95% Confidence Interval) [percentage of participants] |
98.6
65.3%
|
98.5
68.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.61 |
| Comments | Two-side significance level 0.05 | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.58 | |
| Confidence Interval |
(2-Sided) 95% 0.26 to 9.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Reference = COPORT | |
| Title | Number of Participants With Grade 3+ Adverse Events |
|---|---|
| Description | Common Terminology Criteria for Adverse Events (CTCAE) version 4 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. Counts of participants with any grade 3 or higher adverse event, any grade 3 or higher gastrointestinal adverse events, and any grade 3 or higher genitourinary adverse events are reported. Adverse events of any attribution are included. |
| Time Frame | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. Follow-up schedule: end of RT, then 6, 12, 18, 24 months from start of RT, then yearly. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Eligible with adverse event data |
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy |
|---|---|---|
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. |
| Measure Participants | 148 | 141 |
| All adverse events |
25
16.6%
|
20
14%
|
| Gastrointestinal Adverse Events |
3
2%
|
2
1.4%
|
| Genitourinary Adverse Events |
6
4%
|
10
7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Patients with any grade 3 or higher adverse event of any attribution | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.53 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Patients with any grade 3 or higher gastrointestinal adverse event of any attribution | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6929 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Conventional Radiation Therapy, Hypofractionated Radiation Therapy |
|---|---|---|
| Comments | Patients with any grade 3 or higher genitourinary adverse event of any attribution | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2605 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| Time Frame | Adverse events were to be evaluated at end of RT, then every 6 months from start of RT for two years, then yearly. RT dates depends on timing and duration of ADT (optional) and RT. Maximum follow-up at time of of analysis was 3.0 years. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data. | |||
| Arm/Group Title | Conventional Radiation Therapy | Hypofractionated Radiation Therapy | ||
| Arm/Group Description | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional radiation therapy: 62.5 Gy in 25 daily fractions of 2.5 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated radiation therapy: 66.6 Gy in 37 daily fractions of 1.8 Gy to the prostate bed in the absence of disease progression or unacceptable toxicity. Optional androgen deprivation therapy: Any LHRH agonist/antagonist with or without an oral antiandrogen can be used up to a six-month administration dose, starting 7-9 weeks before radiation therapy and may begin as early as 42 days prior to or any time after screening. An oral antiandrogen alone is not allowed. | ||
All Cause Mortality |
||||
| Conventional Radiation Therapy | Hypofractionated Radiation Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/151 (0%) | 0/143 (0%) | ||
Serious Adverse Events |
||||
| Conventional Radiation Therapy | Hypofractionated Radiation Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/148 (0.7%) | 8/141 (5.7%) | ||
| Cardiac disorders | ||||
| Myocardial infarction | 0/148 (0%) | 1/141 (0.7%) | ||
| Gastrointestinal disorders | ||||
| Proctitis | 0/148 (0%) | 1/141 (0.7%) | ||
| Immune system disorders | ||||
| Anaphylaxis | 0/148 (0%) | 1/141 (0.7%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Treatment related secondary malignancy | 0/148 (0%) | 1/141 (0.7%) | ||
| Renal and urinary disorders | ||||
| Cystitis noninfective | 0/148 (0%) | 3/141 (2.1%) | ||
| Hematuria | 0/148 (0%) | 1/141 (0.7%) | ||
| Renal and urinary disorders - Other | 0/148 (0%) | 1/141 (0.7%) | ||
| Renal calculi | 1/148 (0.7%) | 1/141 (0.7%) | ||
| Urinary retention | 0/148 (0%) | 1/141 (0.7%) | ||
| Reproductive system and breast disorders | ||||
| Pelvic pain | 0/148 (0%) | 1/141 (0.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Conventional Radiation Therapy | Hypofractionated Radiation Therapy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 130/148 (87.8%) | 120/141 (85.1%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 8/148 (5.4%) | 5/141 (3.5%) | ||
| Constipation | 17/148 (11.5%) | 17/141 (12.1%) | ||
| Diarrhea | 43/148 (29.1%) | 53/141 (37.6%) | ||
| Gastrointestinal disorders - Other | 13/148 (8.8%) | 17/141 (12.1%) | ||
| Proctitis | 8/148 (5.4%) | 18/141 (12.8%) | ||
| Rectal hemorrhage | 6/148 (4.1%) | 18/141 (12.8%) | ||
| General disorders | ||||
| Fatigue | 80/148 (54.1%) | 62/141 (44%) | ||
| Infections and infestations | ||||
| Urinary tract infection | 8/148 (5.4%) | 2/141 (1.4%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 8/148 (5.4%) | 7/141 (5%) | ||
| Renal and urinary disorders | ||||
| Cystitis noninfective | 12/148 (8.1%) | 10/141 (7.1%) | ||
| Hematuria | 9/148 (6.1%) | 20/141 (14.2%) | ||
| Renal and urinary disorders - Other | 36/148 (24.3%) | 22/141 (15.6%) | ||
| Urinary frequency | 75/148 (50.7%) | 73/141 (51.8%) | ||
| Urinary incontinence | 45/148 (30.4%) | 48/141 (34%) | ||
| Urinary retention | 14/148 (9.5%) | 9/141 (6.4%) | ||
| Urinary tract pain | 11/148 (7.4%) | 15/141 (10.6%) | ||
| Urinary urgency | 43/148 (29.1%) | 45/141 (31.9%) | ||
| Reproductive system and breast disorders | ||||
| Erectile dysfunction | 24/148 (16.2%) | 18/141 (12.8%) | ||
| Vascular disorders | ||||
| Hot flashes | 37/148 (25%) | 32/141 (22.7%) | ||
| Hypertension | 8/148 (5.4%) | 11/141 (7.8%) | ||
Limitations/Caveats
Local and regional failure data was collected as a combined event (local-regional progression) and therefore is reported as a single outcome measure.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
| Name/Title | Wendy Seiferheld |
|---|---|
| Organization | NRG Oncology |
| Phone | 215-574-3208 |
| seiferheldw@nrgoncology.org |
Responsible Party:
NRG Oncology
ClinicalTrials.gov Identifier:
NCT03274687
Other Study ID Numbers:
- NRG-GU003
- NCI-2016-01771
- NRG-GU003
- NRG-GU003
- NRG-GU003
- U10CA180868
First Posted:
Sep 7, 2017
Last Update Posted:
Jun 28, 2022
Last Verified:
May 1, 2022