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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01771 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| NRG-GU003 | |||
| NRG-GU003 | Other Identifier | NRG Oncology | |
| NRG-GU003 | Other Identifier | CTEP | |
| U10CA180868 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
II. 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.
III. 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]).
IV. 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.
V. To compare local failure, regional failure, salvage therapy (i.e. institution of new unplanned anticancer treatment), DM, PCSM, and overall survival (OS) rates.
VI. Assessment of adverse events.
EXPLORATORY OBJECTIVES:
I. To compare utilities for health outcomes using the EuroQol five dimensions questionnaire (EQ-5D).
II. 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.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo conventional radiation therapy for 37 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.
ARM II: Patients undergo hypofractionated radiation therapy for 25 fractions over 5 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.
After completion of study treatment, patients are followed up every 6 months for 2 years and every year for 3 years and thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (conventional radiation therapy) | Experimental | Patients undergo conventional radiation therapy for 37 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation. |
|
| Arm II (hypofractionated radiation therapy | Experimental | Patients undergo hypofractionated radiation therapy for 25 fractions over 5 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Undergo hypofractionated radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two 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. | Baseline (randomization), 2 years |
| Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two 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. | Baseline, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Ethnicity | NIH-required analysis. 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. |
Inclusion Criteria:
PRIOR TO STEP 1 REGISTRATION
Adenocarcinoma of the prostate treated primarily with radical prostatectomy
One of the following pathologic T-classifications: pT2 or pT3
One of the following pathologic N-classifications: pN0, pNX
No clinical evidence of regional lymph node metastasis
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
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
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) questionnaire
Only English and French-speaking patients are eligible to participate as these are the only language the EPIC has been validated in
PRIOR TO STEP 2 REGISTRATION
The EPIC 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 (Considered for NRG-GU002, principal investigator [PI]: Hurwitz)
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;
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Mark K Buyyounouski | NRG Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| University of South Alabama Mitchell Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38483412 | Derived | Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291. |
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NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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Of 298 screened, 296 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Radiation Therapy | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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 (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2019 |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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| Radiation Therapy | Radiation | Undergo conventional radiation therapy |
|
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| 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. |
| Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 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. | 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. |
| Percentage of Participants With Biochemical Failure | 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. | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. |
| Percentage of Participants With Progression | 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. | 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. |
| Percentage of Participants With Local-Regional Failure | 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. | 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. |
| Percentage of Participants Receiving Salvage Therapy | 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. | 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. |
| Percentage of Participants With Distant Metastasis | 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. | 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. |
| Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality) | Cause of death was centrally reviewed. Count and percentage at time of analysis are reported. | 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. |
| Percent of Participants Alive (Overall Survival) | 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. | 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. |
| Number of Participants With Grade 3+ Adverse Events | 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. | 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. |
| Baseline (randomization), 2 years |
| Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Race | NIH-required analysis. 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. | Baseline (randomization), 2 years |
| Mobile |
| Alabama |
| 36688 |
| United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Marin Cancer Care Inc | Greenbrae | California | 94904 | United States |
| Marin General Hospital | Greenbrae | California | 94904 | United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Fremont - Rideout Cancer Center | Marysville | California | 95901 | United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | United States |
| Pomona Valley Hospital Medical Center | Pomona | California | 91767 | United States |
| Kaiser Permanente-Rancho Cordova Cancer Center | Rancho Cordova | California | 95670 | United States |
| Rohnert Park Cancer Center | Rohnert Park | California | 94928 | United States |
| The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | 95678 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| South Sacramento Cancer Center | Sacramento | California | 95823 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente Cancer Treatment Center | South San Francisco | California | 94080 | United States |
| Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | 96161 | United States |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | 80907 | United States |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Helen F Graham Cancer Center | Newark | Delaware | 19713 | United States |
| Christiana Care Health System-Christiana Hospital | Newark | Delaware | 19718 | United States |
| Beebe Health Campus | Rehoboth Beach | Delaware | 19971 | United States |
| TidalHealth Nanticoke / Allen Cancer Center | Seaford | Delaware | 19973 | United States |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | United States |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Cleveland Clinic-Weston | Weston | Florida | 33331 | United States |
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | 31405 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| The Cancer Center of Hawaii-Pali Momi | ‘Aiea | Hawaii | 96701 | United States |
| SIH Cancer Institute | Carterville | Illinois | 62918 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | 60451 | United States |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| UW Health Carbone Cancer Center Rockford | Rockford | Illinois | 61114 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | United States |
| McFarland Clinic - Ames | Ames | Iowa | 50010 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | United States |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | United States |
| Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas | 66606 | United States |
| Ascension Via Christi Hospitals Wichita | Wichita | Kansas | 67214 | United States |
| Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | 42303 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| MaineHealth Maine Medical Center - Portland | Portland | Maine | 04102 | United States |
| MaineHealth Maine Medical Center- Scarborough | Scarborough | Maine | 04074 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Central Maryland Radiation Oncology in Howard County | Columbia | Maryland | 21044 | United States |
| University of Maryland Radiation Oncology Center at Union Hospital | Elkton | Maryland | 21921 | United States |
| UM Baltimore Washington Medical Center/Tate Cancer Center | Glen Burnie | Maryland | 21061 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| Beth Israel Deaconess Hospital-Plymouth | Plymouth | Massachusetts | 02360 | United States |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | 48106 | United States |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | United States |
| McLaren Cancer Institute-Clarkston | Clarkston | Michigan | 48346 | United States |
| Michigan Healthcare Professionals Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | 48038 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Michigan Healthcare Professionals Farmington | Farmington Hills | Michigan | 48334 | United States |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| McLaren Cancer Institute-Flint | Flint | Michigan | 48532 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| Karmanos Cancer Institute at McLaren Greater Lansing | Lansing | Michigan | 48910 | United States |
| University of Michigan Health - Sparrow Lansing | Lansing | Michigan | 48912 | United States |
| McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | 48446 | United States |
| Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | 48154 | United States |
| McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren Cancer Institute-Central Michigan | Mount Pleasant | Michigan | 48858 | United States |
| McLaren Cancer Institute-Owosso | Owosso | Michigan | 48867 | United States |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Trinity Health Saint Joseph Mercy Oakland Hospital | Pontiac | Michigan | 48341 | United States |
| McLaren-Port Huron | Port Huron | Michigan | 48060 | United States |
| Michigan Healthcare Professionals Troy | Troy | Michigan | 48098 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| University of Michigan Health - West | Wyoming | Michigan | 49519 | United States |
| Saint Luke's Hospital of Duluth | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | 56001 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| Mercy Cancer Center - Cape Girardeau | Cape Girardeau | Missouri | 63703 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| North Kansas City Hospital | Kansas City | Missouri | 64116 | United States |
| Kansas City Veterans Affairs Medical Center | Kansas City | Missouri | 64128 | United States |
| The University of Kansas Cancer Center-South | Kansas City | Missouri | 64131 | United States |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | United States |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Bozeman Health Deaconess Hospital | Bozeman | Montana | 59715 | United States |
| Benefis Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Logan Health Medical Center | Kalispell | Montana | 59901 | United States |
| Wentworth-Douglass Hospital | Dover | New Hampshire | 03820 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Lovelace Radiation Oncology | Albuquerque | New Mexico | 87109 | United States |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | United States |
| Memorial Medical Center-Las Cruces | Las Cruces | New Mexico | 88011 | United States |
| Northwell Health Imbert Cancer Center | Bay Shore | New York | 11706 | United States |
| New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Mary Imogene Bassett Hospital | Cooperstown | New York | 13326 | United States |
| Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | 14905 | United States |
| Northwell Health/Center for Advanced Medicine | Lake Success | New York | 11042 | United States |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Dickstein Cancer Treatment Center | White Plains | New York | 10601 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| UNC Health Cancer Care Raleigh | Raleigh | North Carolina | 27607 | United States |
| Novant Cancer Institute Radiation Oncology - Supply | Supply | North Carolina | 28462 | United States |
| Novant Health Cancer Institute Radiation Oncology - Wilmington | Wilmington | North Carolina | 28401 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic Akron General | Akron | Ohio | 44307 | United States |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | United States |
| Geauga Hospital | Chardon | Ohio | 44024 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Mercy Cancer Center-Elyria | Elyria | Ohio | 44035 | United States |
| Cleveland Clinic Cancer Center Independence | Independence | Ohio | 44131 | United States |
| Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | 44906 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | 44060 | United States |
| UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | 44130 | United States |
| University Hospitals Parma Medical Center | Parma | Ohio | 44129 | United States |
| North Coast Cancer Care | Sandusky | Ohio | 44870 | United States |
| UH Seidman Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | 44136 | United States |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | 44691 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Jefferson Abington Hospital | Abington | Pennsylvania | 19001 | United States |
| Crozer-Keystone Regional Cancer Center at Broomall | Broomall | Pennsylvania | 19008 | United States |
| Christiana Care Health System-Concord Health Center | Chadds Ford | Pennsylvania | 19317 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| Crozer Regional Cancer Center at Brinton Lake | Glen Mills | Pennsylvania | 19342 | United States |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | 17109 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Guthrie Medical Group PC-Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | 29316 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Saint Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Self Regional Healthcare | Greenwood | South Carolina | 29646 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| The Radiation Oncology Center-Hilton Head/Bluffton | Hilton Head Island | South Carolina | 29926 | United States |
| Carolina Regional Cancer Center | Myrtle Beach | South Carolina | 29577 | United States |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | United States |
| American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah | 84003 | United States |
| Farmington Health Center | Farmington | Utah | 84025 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Ogden Regional Medical Center | Ogden | Utah | 84405 | United States |
| Utah Valley Regional Medical Center | Provo | Utah | 84604 | United States |
| Riverton Hospital | Riverton | Utah | 84065 | United States |
| Utah Cancer Specialists-Salt Lake City | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| South Jordan Health Center | South Jordan | Utah | 84009 | United States |
| Dartmouth Cancer Center - North | Saint Johnsbury | Vermont | 05819 | United States |
| Augusta Health Center for Cancer and Blood Disorders | Fishersville | Virginia | 22939 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Overlake Medical Center | Bellevue | Washington | 98004 | United States |
| Ascension Saint Elizabeth Hospital | Appleton | Wisconsin | 54915 | United States |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus | Brookfield | Wisconsin | 53045 | United States |
| Mayo Clinic Health System Eau Claire Hospital-Luther Campus | Eau Claire | Wisconsin | 54703 | United States |
| Ascension Saint Francis - Reiman Cancer Center | Franklin | Wisconsin | 53132 | United States |
| Aurora Cancer Care-Grafton | Grafton | Wisconsin | 53024 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | 53142 | United States |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Mayo Clinic Health System-Franciscan Healthcare | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | United States |
| Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | 54143 | United States |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | United States |
| Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Ascension Mercy Hospital | Oshkosh | Wisconsin | 54904 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Ascension All Saints Hospital | Racine | Wisconsin | 53405 | United States |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | United States |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | United States |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | United States |
| Aurora West Allis Medical Center | West Allis | Wisconsin | 53227 | United States |
| Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | 53095 | United States |
| Aspirus Cancer Care - Wisconsin Rapids | Wisconsin Rapids | Wisconsin | 54494 | United States |
| Arthur J E Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| Juravinski Cancer Centre at Hamilton Health Sciences | Hamilton | Ontario | L8V 5C2 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Centre De Sante Et De Services Sociaux De Chicoutimi | Chicoutimi | Quebec | G7H 5H6 | Canada |
| CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 3E4 | Canada |
| The Research Institute of the McGill University Health Centre (MUHC) | Montreal | Quebec | H3H 2R9 | Canada |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) | Québec | Quebec | G1R 2J6 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| FG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
| Eligible |
|
| Eligible With Adverse Event Data |
|
| COMPLETED | Participants contributing data to results are considered to have completed the study. |
|
| NOT COMPLETED |
|
|
Eligible participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Radiation Therapy | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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. |
| BG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Years | Count of Participants | Participants |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| EPIC Group | 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. The bowel domain contains 14 items. | Count of Participants | Participants |
| |||||||||||||||||
| Prior androgen deprivation therapy (ADT) | Count of Participants | Participants |
| ||||||||||||||||||
| Prostate-specific antigen (PSA) ng/mL | Prostate-specific antigen (PSA) is a protein made by the prostate gland and found in the blood. PSA blood levels may be higher than normal in men who have prostate cancer, benign prostatic hyperplasia (BPH), or infection or inflammation of the prostate gland, and are often used to monitor patients who have been treated for prostate cancer to see if their cancer has recurred. | Count of Participants | Participants |
| |||||||||||||||||
| Gleason score | Gleason score describes prostate cancer based on how abnormal the cancer cells in a biopsy sample look under a microscope. Cells are scored 1-5 with 1 indicating "low-grade" looking similar to normal cells and 5 indicating "high-grade" barely resembling normal cells due to mutation. A pathologist assigns a Gleason grade to the first and second most predominant patterns in the biopsy. The two grades are added together to calculate the Gleason score (between 2 and 10). Cancers with lower scores tend to be less aggressive, while cancers with higher scores end to be more aggressive. | Count of Participants | Participants |
| |||||||||||||||||
| T-Stage | Tumor stage per the American Joint Committee on Cancer (AJCC) 7th ed. refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. | Count of Participants | Participants |
| |||||||||||||||||
| N-Stage | Regional lymph nodes staging per American Joint Committee on Cancer (AJCC) refers to the number and/or extent of spread of lymph nodes that contain cancer. A higher number means the cancer is in more lymph nodes, farther away from the original tumor. N0 means lymph nodes aren't involved; NX means the lymph nodes could not be assessed. | Count of Participants | Participants |
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| Zubrod | 0 = Asymptomatic; 1 = Symptomatic but completely ambulatory; 2 = Symptomatic, <50% in bed during the day; 3 = Symptomatic, >50% in bed, but not bedbound; 4 = Bedbound; 5 = Death | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two 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. | Eligible participants with baseline and two-year data | Posted | Mean | Standard Deviation | units on a scale | Baseline (randomization), 2 years |
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| Primary | Change in Bowel Domain of the Expanded Prostate Cancer Index (EPIC) at Two 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. | Eligible participants with baseline and two-year data | Posted | Mean | Standard Error | units on a scale | Baseline, 2 years |
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| Secondary | Change in Urinary Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of Radiation Therapy (RT), 6 Months, 1 and 5 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. | Eligible participants with baseline data | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | Change in Bowel Domain Score of the Expanded Prostate Cancer Index (EPIC) at End of RT, 6 Months, 1 and 5 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. | Eligible participants with baseline data | Posted | Mean | Standard Deviation | units on a scale | 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. |
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| Secondary | Percentage of Participants With Biochemical Failure | 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. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization to last follow-up. Maximum follow-up at time of analysis was 3.0 years. |
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| Secondary | Percentage of Participants With Progression | 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. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants With Local-Regional Failure | 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. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants Receiving Salvage Therapy | 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. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants With Distant Metastasis | 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. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Percentage of Participants Who Died From Prostate Cancer (Prostate Cancer Specific Mortality) | Cause of death was centrally reviewed. Count and percentage at time of analysis are reported. | Eligible participants | Posted | Count of Participants | Participants | 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. |
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| Secondary | Percent of Participants Alive (Overall Survival) | 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. | Eligible participants | Posted | Number | 95% Confidence Interval | percentage of participants | 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. |
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| Secondary | Number of Participants With Grade 3+ Adverse Events | 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. | Eligible with adverse event data | Posted | Count of Participants | Participants | 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. |
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| Other Pre-specified | Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Ethnicity | NIH-required analysis. 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. | Eligible participants with baseline and two-year data. Data stratified by ethnicity. | Posted | Mean | Standard Deviation | units on a scale | Baseline (randomization), 2 years |
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| Other Pre-specified | Change in Urinary Domain of the Expanded Prostate Cancer Index (EPIC) at Two Years by Race | NIH-required analysis. 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. | Eligible participants with baseline and two-year data. Data stratified by race. | Posted | Mean | Standard Deviation | units on a scale | Baseline (randomization), 2 years |
|
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.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Radiation Therapy | Conventional post-prostatectomy radiation therapy (COPORT) over 7 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Conventional 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. | 0 | 151 | 1 | 148 | 130 | 148 |
| EG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. | 0 | 143 | 8 | 141 | 120 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Local and regional failure data was collected as a combined event (local-regional progression) and therefore is reported as a single outcome measure.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | 215-574-3208 | seiferheldw@nrgoncology.org |
| Feb 2, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 26, 2019 | Feb 2, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D011827 | Radiation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
Not provided
Not provided
| 60 - 69 years |
|
| ≥ 70 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| B Score Group (bowel domain score > 96, urinary domain score ≤ 84) |
|
| C Score Group (bowel domain score ≤ 96, urinary domain score > 84) |
|
| D Score Group (bowel domain score ≤ 96, urinary domain score ≤ 84) |
|
| Yes |
|
| 0.6 - 1.0 |
|
| 1.1 - 1.5 |
|
| 1.6 - 2.0 |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| T3 |
|
| N0 |
|
| 1 |
|
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation.
Hypofractionated 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.
|
|
|
| OG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
|
|
|
| OG001 |
| Hypofractionated Radiation Therapy |
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
|
|
|
| OG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
|
|
|
| OG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
|
|
|
| OG001 | Hypofractionated Radiation Therapy | Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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 Radiation Therapy |
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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. |
|
|
|
| OG001 |
| Hypofractionated Radiation Therapy |
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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: 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: 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 Radiation Therapy |
Hypofractionated post-prostatectomy radiation therapy (HYPORT) over 5 weeks. Patients may also receive optional androgen deprivation therapy per doctor recommendation. Hypofractionated 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: 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. |
|
|