| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000701128 | |||
| NCI-2011-02674 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to high-risk groups as listed in the Disease Characteristics of this abstract, type of radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and duration of androgen-deprivation therapy (short-term [4-6 months] vs long-term [32 months]). Patients are randomized to 1 of 2 treatment arms.
All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 4-6 or 32 months.
Radiotherapy begins within 8 weeks after beginning LHRH agonist/antagonist injection.
Patients may undergo blood and urine sample collection for correlative studies. Primary tumor tissue samples may also be collected.
Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and periodically during treatment. Patients who participate in the QOL portion of the study must also agree to periodic blood collection.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Active Comparator | Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol. |
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| Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Experimental | Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| three-dimensional conformal radiotherapy | Radiation | Daily fractions |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Alive (Overall Survival) | Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. | From randomization to death or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Died Due to Prostate Cancer | Prostate cancer death rates were estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis. | From randomization to death due to prostate cancer or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
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DISEASE CHARACTERISTICS:
Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
Gleason score 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml (includes intermediate and high risk patients);
Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/ml
-ORGleason score 6 + ≥ 50% (positive) biopsies + PSA < 50 ng/ml;
Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute).
Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
*Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration.
Study entry PSA should not be obtained during the following time frames: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
Platelets ≥ 100,000 cells/mm3;
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
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| Name | Affiliation | Role |
|---|---|---|
| Mack Roach, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | 36688 | United States | ||
| Anchorage Associates in Radiation Medicine |
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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| ID | Title | Description |
|---|---|---|
| FG000 | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol. |
| 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 | Sep 28, 2022 |
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| intensity modulated radiotherapy | Radiation | Daily fractions |
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| Brachytherapy | Radiation | Implant |
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| Anti-androgen | Drug | Tablet |
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| luteinizing hormone-releasing hormone (LHRH) agonist or antagonist | Drug | Injection |
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| Percentage of Participants With Distant Metastasis | Distant metastasis rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without distant metastasis at time of analysis. | From date of randomization to distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
| Percentage of Participants With Biochemical Failure | Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without biochemical failure at time of analysis. | From date of randomization to the date of biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
| Number of Participants by Highest Grade Acute Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Acute adverse events are defined as those occurring within 30 days after the completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From protocol treatment start date to 30 days from completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique. |
| Number of Participants by Highest Grade Late Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Late adverse events are defined as occurring ≥ 30 days after end of RT (approximately weeks 19-22, depending on boost technique). Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | From 30 days after completion of radiation therapy (approximately weeks 19-22, depending on boost technique) to highest grade late adverse event. Median follow-up at time of analysis was 6.7 years. |
| EPIC-26 Urinary Bowel Domain Score Change From Baseline at 6 Months | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. | Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique. |
| EPIC-26 Urinary Irritative/Obstructive Subscore Change From Baseline at 6 Months | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. | Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique. |
| PROMIS Fatigue Score Change From Baseline Line at Last Week of Radiation Treatment | The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Baseline and last week of radiation treatment, approximately 19-22 weeks, depending on boost technique. |
| Quality Adjusted Life Years (QALYs) | Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Baseline; the week prior to radiation therapy (RT); the last week of RT; 6 months, 1 year, and 5 years after RT. RT begins about weeks 8-10 after starting protocol therapy and ends about weeks 19-22, depending on boost technique. |
| Anchorage |
| Alaska |
| 98508 |
| United States |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | 99508 | United States |
| Anchorage Oncology Centre | Anchorage | Alaska | 99508 | United States |
| Katmai Oncology Group | Anchorage | Alaska | 99508 | United States |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | United States |
| Fairbanks Memorial Hospital | Fairbanks | Alaska | 99701 | United States |
| Arizona Breast Cancer Specialists-Gilbert | Gilbert | Arizona | 85297 | United States |
| Arizona Center for Cancer Care-Peoria | Peoria | Arizona | 85381 | United States |
| Cancer Center at Saint Joseph's | Phoenix | Arizona | 85004 | United States |
| Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States |
| Arizona Breast Cancer Specialists-Phoenix | Phoenix | Arizona | 85027 | United States |
| Arizona Oncology-Deer Valley Center | Phoenix | Arizona | 85027 | United States |
| 21st Century Oncology-Scottsdale | Scottsdale | Arizona | 85251 | United States |
| Arizona Breast Cancer Specialists | Scottsdale | Arizona | 85251 | United States |
| Arizona Breast Cancer Specialists-Scottsdale | Scottsdale | Arizona | 85258 | United States |
| Arizona Oncology Services Foundation | Scottsdale | Arizona | 85260 | United States |
| Arizona Center for Cancer Care-Surprise | Surprise | Arizona | 85374 | United States |
| Arizona Oncology Associates-West Orange Grove | Tucson | Arizona | 85704 | United States |
| University of Arizona Cancer Center-Orange Grove Campus | Tucson | Arizona | 85704 | United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | United States |
| CHI Saint Vincent Cancer Center Hot Springs | Hot Springs | Arkansas | 71913 | United States |
| Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | Jonesboro | Arkansas | 72401 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | 95603 | United States |
| AIS Cancer Center at San Joaquin Community Hospital | Bakersfield | California | 93301 | United States |
| Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | 94704 | United States |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | 91505 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Cameron Park | Cameron Park | California | 95682 | United States |
| Mercy San Juan Medical Center | Carmichael | California | 95608 | United States |
| Adventist Health Cancer Care Center Chico | Chico | California | 95973 | United States |
| Fresno Cancer Center | Fresno | California | 93720 | United States |
| Saint Agnes Medical Center | Fresno | California | 93720 | United States |
| Marin General Hospital | Greenbrae | California | 94904 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Tibor Rubin VA Medical Center | Long Beach | California | 90822 | United States |
| Los Angeles County-USC 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 |
| Mercy UC Davis Cancer Center | Merced | California | 95340 | United States |
| Memorial Medical Center | Modesto | California | 95355 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Kaiser Permanente Oakland-Broadway | Oakland | California | 94611 | United States |
| Desert Regional Medical Center | Palm Springs | California | 92262 | United States |
| Palo Alto Medical Foundation Health Care | Palo Alto | California | 94301 | 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 |
| Sutter Cancer Centers Radiation Oncology Services-Roseville | Roseville | California | 95661 | United States |
| The Permanente Medical Group-Roseville Radiation Oncology | Roseville | California | 95678 | United States |
| Mercy Cancer Center - Sacramento | Sacramento | California | 95816 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| South Sacramento Cancer Center | Sacramento | California | 95823 | United States |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | United States |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States |
| Santa Clara Valley Medical Center | San Jose | California | 95128 | 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 |
| Saint Joseph's Medical Center | Stockton | California | 95204 | United States |
| Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | 94086 | United States |
| Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee | California | 96161 | United States |
| Sutter Cancer Centers Radiation Oncology Services-Vacaville | Vacaville | California | 95687 | United States |
| Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | 80012 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | 80304 | United States |
| UCHealth Memorial Hospital Central | Colorado Springs | Colorado | 80909 | United States |
| Porter Adventist Hospital | Denver | Colorado | 80210 | United States |
| Shaw Cancer Center | Edwards | Colorado | 81632 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| Longmont United Hospital | Longmont | Colorado | 80501 | United States |
| McKee Medical Center | Loveland | Colorado | 80539 | United States |
| Parker Adventist Hospital | Parker | Colorado | 80138 | United States |
| Hartford HealthCare - Saint Vincent's Medical Center | Bridgeport | Connecticut | 06606 | United States |
| Smilow Cancer Hospital Care Center at Saint Francis | Hartford | Connecticut | 06105 | United States |
| Middlesex Hospital | Middletown | Connecticut | 06457 | 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 |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Broward Health North | Deerfield Beach | Florida | 33064 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Baptist Medical Center South | Jacksonville | Florida | 32258 | United States |
| Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Cancer Center of Putnam | Palatka | Florida | 32177 | United States |
| GenesisCare USA - Plantation | Plantation | Florida | 33324 | United States |
| James A. Haley Veterans Affairs Hospital | Tampa | Florida | 33612 | United States |
| Florida Cancer Affiliates | Trinity | Florida | 34655 | 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 |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | United States |
| John B Amos Cancer Center | Columbus | Georgia | 31904 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Piedmont Fayette Hospital | Fayetteville | Georgia | 30214 | United States |
| Northeast Georgia Medical Center-Gainesville | Gainesville | Georgia | 30501 | United States |
| Central Georgia Gynecologic Oncology | Macon | Georgia | 31201 | 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 |
| Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | 83706 | United States |
| Kootenai Health - Coeur d'Alene | Coeur d'Alene | Idaho | 83814 | United States |
| Idaho Urologic Institute-Meridian | Meridian | Idaho | 83642 | United States |
| Kootenai Clinic Cancer Services - Post Falls | Post Falls | Idaho | 83854 | United States |
| Kootenai Cancer Clinic | Sandpoint | Idaho | 83864 | United States |
| Saint Luke's Cancer Institute - Twin Falls | Twin Falls | Idaho | 83301 | United States |
| Northwest Community Hospital | Arlington Heights | Illinois | 60005 | United States |
| Rush - Copley Medical Center | Aurora | Illinois | 60504 | United States |
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Advocate Illinois Masonic Medical Center | Chicago | Illinois | 60657 | United States |
| UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital | Chicago | Illinois | 60657 | 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 |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| SwedishAmerican Regional Cancer Center/ACT | Rockford | Illinois | 61114 | United States |
| Saint John's Hospital | Springfield | Illinois | 62702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Southwest Illinois Health Services LLP | Swansea | Illinois | 62226 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Radiation Oncology Associates PC | Fort Wayne | Indiana | 46804 | United States |
| Parkview Hospital Randallia | Fort Wayne | Indiana | 46805 | United States |
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| McFarland Clinic PC - Ames | Ames | Iowa | 50010 | United States |
| Saint Luke's Hospital | Cedar Rapids | Iowa | 52402 | United States |
| Mercy Hospital | Cedar Rapids | Iowa | 52403 | United States |
| Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Central Care Cancer Center - Garden City | Garden City | Kansas | 67846 | United States |
| Saint Catherine Hospital | Garden City | Kansas | 67846 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Olathe Health Cancer Center | 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 |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Owensboro Health Mitchell Memorial Cancer Center | Owensboro | Kentucky | 42303 | United States |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | United States |
| Mary Bird Perkins Cancer Center - Covington | Covington | Louisiana | 70433 | United States |
| Mary Bird Perkins Cancer Center - Houma | Houma | Louisiana | 70360 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana | 70006 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Touro Infirmary | New Orleans | Louisiana | 70115 | United States |
| Ochsner Medical Center Jefferson | New Orleans | Louisiana | 70121 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | United States |
| Saint Agnes Hospital | Baltimore | Maryland | 21229 | United States |
| UM Upper Chesapeake Medical Center | Bel Air | Maryland | 21014 | 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 |
| TidalHealth Peninsula Regional | Salisbury | Maryland | 21801 | United States |
| UM Saint Joseph Medical Center | Towson | Maryland | 21204 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Saint Anne's Hospital | Fall River | Massachusetts | 02721 | United States |
| Cape Cod Hospital | Hyannis | Massachusetts | 02601 | United States |
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
| Beth Israel Deaconess Hospital-Plymouth | Plymouth | Massachusetts | 02360 | United States |
| Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Veteran's Administration Medical Center - Ann Arbor | Ann Arbor | Michigan | 48105 | United States |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| McLaren Cancer Institute-Bay City | Bay City | Michigan | 48706 | United States |
| Henry Ford Cancer Institute-Downriver | Brownstown | Michigan | 48183 | United States |
| GenesisCare USA - Clarkston | Clarkston | Michigan | 48346 | United States |
| McLaren Cancer Institute-Clarkston | Clarkston | Michigan | 48346 | United States |
| Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | 48038 | United States |
| Beaumont Hospital - Dearborn | Dearborn | Michigan | 48124 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Ascension Saint John Hospital | Detroit | Michigan | 48236 | United States |
| GenesisCare USA - Farmington Hills | Farmington Hills | Michigan | 48334 | United States |
| Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| Beaumont Hospital - Farmington Hills | Farmington Hills | Michigan | 48336 | United States |
| McLaren Cancer Institute-Flint | Flint | Michigan | 48532 | United States |
| Mercy Health Saint Mary's | Grand Rapids | Michigan | 49503 | United States |
| Spectrum Health at Butterworth Campus | 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 |
| Sparrow Hospital | Lansing | Michigan | 48912 | United States |
| McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | 48446 | United States |
| Saint Mary Mercy 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 |
| Mercy Health Mercy Campus | Muskegon | Michigan | 49444 | United States |
| McLaren Cancer Institute-Owosso | Owosso | Michigan | 48867 | United States |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | United States |
| 21st Century Oncology-Pontiac | Pontiac | Michigan | 48341 | United States |
| Saint Joseph Mercy Oakland | Pontiac | Michigan | 48341 | United States |
| McLaren-Port Huron | Port Huron | Michigan | 48060 | United States |
| William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| Ascension Saint Mary's Hospital | Saginaw | Michigan | 48601 | United States |
| Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | 49085 | United States |
| William Beaumont Hospital - Troy | Troy | Michigan | 48085 | United States |
| GenesisCare USA - Troy | Troy | Michigan | 48098 | United States |
| Saint John Macomb-Oakland Hospital | Warren | Michigan | 48093 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Mayo Clinic Health System in Albert Lea | Albert Lea | Minnesota | 56007 | United States |
| Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | 56601 | United States |
| Saint Luke's Hospital of Duluth | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic Health Systems-Mankato | Mankato | Minnesota | 56001 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Monticello Cancer Center | Monticello | Minnesota | 55362 | United States |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Singing River Hospital | Pascagoula | Mississippi | 39581 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | 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 |
| Freeman Health System | Joplin | Missouri | 64804 | 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 |
| Delbert Day Cancer Institute at PCRMC | Rolla | Missouri | 65401 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| CoxHealth South Hospital | Springfield | Missouri | 65807 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Veteran's Affairs Medical Center - Saint Louis | St Louis | Missouri | 63125 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | United States |
| Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | 59405 | United States |
| Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Exeter Hospital | Exeter | New Hampshire | 03833 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| AtlantiCare Surgery Center | Egg Harbor | New Jersey | 08234 | United States |
| Virtua Memorial | Mount Holly | New Jersey | 08060 | United States |
| Inspira Medical Center Mullica Hill | Mullica Hill | New Jersey | 08062 | United States |
| Penn Medicine Princeton Health | Plainsboro | New Jersey | 08536 | United States |
| Sidney Kimmel Cancer Center Washington Township | Sewell | New Jersey | 08080 | United States |
| Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | 08876 | United States |
| Sparta Cancer Treatment Center | Sparta | New Jersey | 07871 | United States |
| Inspira Medical Center Vineland | Vineland | New Jersey | 08360 | United States |
| Virtua Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | 88011 | United States |
| South Shore University Hospital | Bay Shore | New York | 11706 | United States |
| New York-Presbyterian/Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Sands Cancer Center | Canandiaqua | New York | 14424 | 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 |
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Wilmot Cancer Institute Radiation Oncology at Greece | Rochester | New York | 14606 | United States |
| Highland Hospital | Rochester | New York | 14620 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| James J Peters VA Medical Center | The Bronx | New York | 10468 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Durham VA Medical Center | Durham | North Carolina | 27705 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Coleman Radiation Center-Carteret General Hospital | Morehead City | North Carolina | 28557 | United States |
| FirstHealth of the Carolinas-Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| UNC Rex Cancer Center | Raleigh | North Carolina | 27607 | United States |
| NHRMC Radiation Oncology - Supply | Supply | North Carolina | 28462 | United States |
| NHRMC Radiation Oncology - 16th Street | Wilmington | North Carolina | 28401 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Sanford Broadway Medical Center | Fargo | North Dakota | 58122 | United States |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | United States |
| Cleveland Clinic Akron General | Akron | Ohio | 44307 | United States |
| Summa Health System - Barberton Campus | Barberton | Ohio | 44203 | United States |
| UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | 44122 | United States |
| Cleveland Clinic Mercy Hospital | Canton | Ohio | 44708 | 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 |
| The Mark H Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Mount Carmel Health Center West | Columbus | Ohio | 43222 | 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 |
| Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio | 43537 | United States |
| Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | 44124 | United States |
| Summa Health Medina Medical Center | Medina | Ohio | 44256 | 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 |
| Saint Charles Hospital | Oregon | Ohio | 43616 | United States |
| University Hospitals Parma Medical Center | Parma | Ohio | 44129 | United States |
| Southern Ohio Medical Center | Portsmouth | Ohio | 45662 | United States |
| University Hospitals Portage Medical Center | Ravenna | Ohio | 44266 | United States |
| UH Seidman Cancer Center at Salem Regional Medical Center | Salem | Ohio | 44460 | 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 |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Mercy Health - Saint Anne Hospital | Toledo | Ohio | 43623 | United States |
| UHHS-Westlake Medical Center | Westlake | Ohio | 44145 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | 44691 | United States |
| Wright-Patterson Medical Center | Wpafb | Ohio | 45433 | United States |
| Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | 43701 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Saint John Medical Center | Tulsa | Oklahoma | 74104 | United States |
| Clackamas Radiation Oncology Center | Clackamas | Oregon | 97015 | United States |
| Three Rivers Community Hospital | Grants Pass | Oregon | 97527 | United States |
| Providence Medford Medical Center | Medford | Oregon | 97504 | United States |
| Rogue Valley Medical Center | Medford | Oregon | 97504 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Kaiser Permanente Northwest | Portland | Oregon | 97227 | United States |
| Jefferson Abington Hospital | Abington | Pennsylvania | 19001 | United States |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Northeast Radiation Oncology Center | Dunmore | Pennsylvania | 18512 | United States |
| Ephrata Cancer Center | Ephrata | Pennsylvania | 17522 | United States |
| Fox Chase Cancer Center Buckingham | Furlong | Pennsylvania | 18925 | United States |
| Adams Cancer Center | Gettysburg | Pennsylvania | 17325 | United States |
| Cherry Tree Cancer Center | Hanover | Pennsylvania | 17331 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Sechler Family Cancer Center | Lebanon | Pennsylvania | 17042 | United States |
| Upper Delaware Valley Cancer Center | Milford | Pennsylvania | 18337 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| Reading Hospital | West Reading | Pennsylvania | 19611 | United States |
| Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Asplundh Cancer Pavilion | Willow Grove | Pennsylvania | 19090 | United States |
| WellSpan Health-York Hospital | York | Pennsylvania | 17403 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | 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 |
| Tidelands Georgetown Memorial Hospital | Georgetown | South Carolina | 29440 | 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 |
| Prisma Health Cancer Institute - Greer | Greer | South Carolina | 29650 | 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 |
| Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | 29672 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| Wellmont Holston Valley Hospital and Medical Center | Kingsport | Tennessee | 37660 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Cancer Center | Abilene | Texas | 79606 | United States |
| Texas Oncology PA Beaumont | Beaumont | Texas | 77702 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Texas Oncology - Denison Cancer Center | Denison | Texas | 75020 | United States |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| Texas Oncology - Fort Worth Cancer Center | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0565 | United States |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| UTMB Cancer Center at Victory Lakes | League City | Texas | 77573 | United States |
| Texas Oncology-McAllen | McAllen | Texas | 78503 | United States |
| Texas Oncology-McKinney | McKinney | Texas | 75071 | United States |
| West Texas Cancer Center | Odessa | Texas | 79761 | United States |
| Texas Oncology-Plano West | Plano | Texas | 75093 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Texas Oncology Cancer Center Sugar Land | Sugar Land | Texas | 77479 | United States |
| Deke Slayton Cancer Center | Webster | Texas | 77598 | United States |
| American Fork Hospital / Huntsman Intermountain Cancer Center | American Fork | Utah | 84003 | United States |
| Sandra L Maxwell Cancer Center | Cedar City | Utah | 84720 | 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 |
| 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 |
| Dixie Medical Center Regional Cancer Center | St. George | Utah | 84770 | United States |
| Southwestern Vermont Medical Center | Bennington | Vermont | 05201 | United States |
| Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners | Vermont | 05602 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Norris Cotton Cancer Center-North | Saint Johnsbury | Vermont | 05819 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Augusta Health Center for Cancer and Blood Disorders | Fishersville | Virginia | 22939 | United States |
| Sentara Cancer Institute at Sentara CarePlex Hospital | Hampton | Virginia | 23666 | United States |
| Sentara Rockingham Memorial Hospital Hahn Cancer Center | Harrisonburg | Virginia | 22801 | United States |
| Bon Secours DePaul Medical Center | Norfolk | Virginia | 23505 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Hunter Holmes McGuire Veterans Administration Medical Center | Richmond | Virginia | 23249 | United States |
| Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia | 24014 | United States |
| Sentara Obici Hospital | Suffolk | Virginia | 23434 | United States |
| Sentara Virginia Beach General Hospital | Virginia Beach | Virginia | 23454 | United States |
| Saint Francis Hospital | Federal Way | Washington | 98003 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | 98902 | United States |
| United Hospital Center | Bridgeport | West Virginia | 26330 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | 54409 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| ThedaCare Regional Medical Center - Appleton | Appleton | Wisconsin | 54911 | United States |
| Ascension Southeast Wisconsin Hospital - Elmbrook Campus | Brookfield | Wisconsin | 53045 | United States |
| Marshfield Medical Center-EC Cancer Center | Eau Claire | Wisconsin | 54701 | 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 |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | 54303 | United States |
| Aurora BayCare Medical Center | Green Bay | Wisconsin | 54311 | United States |
| UW Cancer Center Johnson Creek | Johnson Creek | Wisconsin | 53038 | 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 Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | 54143 | United States |
| Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | 54449 | United States |
| Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | 53051 | United States |
| Ascension Columbia Saint Mary's Hospital Ozaukee | Mequon | Wisconsin | 53097 | United States |
| Ascension Southeast Wisconsin Hospital - Saint Joseph Campus | Milwaukee | Wisconsin | 53210 | United States |
| Ascension Columbia Saint Mary's Hospital - Milwaukee | Milwaukee | Wisconsin | 53211 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Zablocki Veterans Administration Medical Center | Milwaukee | Wisconsin | 53295 | United States |
| Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | 54548 | United States |
| Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | 54904 | United States |
| Ascension All Saints Hospital | Racine | Wisconsin | 53405 | United States |
| Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | 54868 | United States |
| HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin | 53081 | United States |
| Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | 53081 | United States |
| Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | 54482 | United States |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| Aurora Medical Center in Summit | Summit | Wisconsin | 53066 | United States |
| Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | 54241 | United States |
| Aspirus Regional Cancer Center | Wausau | Wisconsin | 54401 | 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 |
| Billings Clinic-Cody | Cody | Wyoming | 82414 | United States |
| Tom Baker Cancer Centre | Calgary | Alberta | T2N 4N2 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| BCCA-Cancer Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| BCCA-Fraser Valley Cancer Centre | Surrey | British Columbia | V3V 1Z2 | Canada |
| Doctor H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| QEII Health Sciences Centre/Nova Scotia Health Authority | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Stronach Regional Health Centre at Southlake | Newmarket | Ontario | L3Y 2P9 | Canada |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University Department of Oncology | Montreal | Quebec | H2W 1S6 | 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 |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | 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 |
| Pamela Youde Nethersole Eastern Hospital | Chai Wan | Hong Kong |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| National University Hospital Singapore | Singapore | 119074 | Singapore |
| National Cancer Centre Singapore | Singapore | 169610 | Singapore |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| FG001 | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
| Eligible |
|
| COMPLETED | Participants contributing data to any results are considered to have completed the study. |
|
| NOT COMPLETED |
|
|
Eligible randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol. |
| BG001 | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
| 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, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Risk group (per stratification) | Gleason score (2-10) reflects tumor grade, with higher scores indicating more aggressive cancer. Prostate-specific antigen (PSA) blood level reflects tumor burden, with higher values indicating worse disease. Clinical tumor stage per AJCC 7th edition describes the size and extent of the primary tumor; higher T-stage (number) and substage (letters within a stage) indicate more advanced disease. | Count of Participants | Participants |
| |||||||||||||||
| Type of radiation boost (per stratification) | Count of Participants | Participants |
| ||||||||||||||||
| Duration of androgen deprivation therapy (ADT) (per stratification) | 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 | Percentage of Participants Alive (Overall Survival) | Survival rates are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis. | Eligible participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to death or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants Who Died Due to Prostate Cancer | Prostate cancer death rates were estimated using the cumulative incidence method, treating death due to other causes as a competing risk, and otherwise censoring participants alive at time of analysis. | Eligible participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From randomization to death due to prostate cancer or last follow-up. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Distant Metastasis | Distant metastasis rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without distant metastasis at time of analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization to distant metastasis, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Biochemical Failure | Biochemical failure is defined as a rise in prostate-specific antigen (PSA) of ≥2.0 ng/mL above the post-treatment PSA nadir following radiation therapy for prostate cancer (Phoenix definition). Biochemical failure rates were estimated using the cumulative incidence method, treating death as a competing risk, and otherwise censoring participants alive without biochemical failure at time of analysis. | Eligible participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From date of randomization to the date of biochemical failure, death, or last follow-up, whichever occurs first. Median follow-up at time of analysis was 6.8 years. Five- and ten-year estimates are reported. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Highest Grade Acute Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Acute adverse events are defined as those occurring within 30 days after the completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Adverse events were assessed in eligible participants who started protocol treatment. | Posted | Oct 2026 | Count of Participants | Participants | From protocol treatment start date to 30 days from completion of radiation therapy. RT begins approximately weeks 8-10 after starting protocol therapy and ends approximately weeks 19-22, depending on boost technique. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Highest Grade Late Adverse Event Reported | Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Late adverse events are defined as occurring ≥ 30 days after end of RT (approximately weeks 19-22, depending on boost technique). Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. | Posted | Oct 2026 | Count of Participants | Participants | From 30 days after completion of radiation therapy (approximately weeks 19-22, depending on boost technique) to highest grade late adverse event. Median follow-up at time of analysis was 6.7 years. |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EPIC-26 Urinary Bowel Domain Score Change From Baseline at 6 Months | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. | Not Posted | Dec 2026 | Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | EPIC-26 Urinary Irritative/Obstructive Subscore Change From Baseline at 6 Months | The Expanded Prostate Cancer Index Composite-26 (EPIC-26) measures health-related quality of life in men with prostate cancer across urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal domains. Possible scores range from 0 to 100, with higher scores indicating better quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline. | Not Posted | Dec 2026 | Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PROMIS Fatigue Score Change From Baseline Line at Last Week of Radiation Treatment | The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible raw scores range from 29.4 to 83.2 (higher raw score indicating greater fatigue) and are converted into standardized T-scores (mean=50, standard deviation=10) with higher scores also indicating greater fatigue. Change score is calculated by subtracting baseline T-score from later T-score, with a positive change score indicating increased fatigue. | Not Posted | Dec 2026 | Baseline and last week of radiation treatment, approximately 19-22 weeks, depending on boost technique. | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality Adjusted Life Years (QALYs) | Quality adjusted life years is calculated as the weighted sum of the number of years spent in different health states. The weight value is a utility score between 0 (worst health state) and 1 (best health state) derived from the EQ-5D questionnaire, designed to describe and value health based on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | The protocol states that this endpoint would be addressed if and only if the primary endpoint supports the primary hypothesis, therefore data is not reported. | Posted | Oct 2026 | Baseline; the week prior to radiation therapy (RT); the last week of RT; 6 months, 1 year, and 5 years after RT. RT begins about weeks 8-10 after starting protocol therapy and ends about weeks 19-22, depending on boost technique. |
|
From randomization to death or last follow-up. Median follow-up at time of analysis was 6.7 years.
All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started protocol treatment.
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 | Prostate/Seminal Vesicle Radiotherapy + ADT + Prostate Boost (Arm 1) | Participants receive androgen deprivation therapy (ADT), consisting of an oral anti androgen plus a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, for a total duration of 4, 6, or 32 months. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the prostate and entire seminal vesicles, delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost to the prostate and proximal seminal vesicles follows, using either IMRT (34.2 Gy in 19 fractions, with protocol specified dose reduction options when indicated) or brachytherapy delivered as low dose rate (LDR) or high dose rate (HDR) implant per protocol. | 257 | 1,228 | 114 | 1,231 | 1,081 | 1,231 |
| EG001 | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. | 257 | 1,245 | 107 | 1,239 | 1,093 | 1,239 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Aortic valve disease | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cardiac disorders - Other | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Constrictive pericarditis | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Colonic fistula | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gastroparesis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Rectal fistula | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Rectal necrosis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Death NOS | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Fever | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Flu like symptoms | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Sudden death NOS | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Bladder infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Endocarditis infective | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Infections and infestations - Other | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Prostate infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Small intestine infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urostomy obstruction | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | CTCAE v4.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Investigations - Other | Investigations | CTCAE v4.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Non-systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Non-systematic Assessment |
| |
| Treatment related secondary malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Psychiatric disorders - Other | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Renal calculi | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Ejaculation disorder | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Surgical and medical procedures - Other | Surgical and medical procedures | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Vascular disorders - Other | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorders - Other | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Pain | General disorders and administration site conditions | CTCAE v4.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE v4.0 | Non-systematic Assessment |
|
The Data Monitoring Committee (DMC) recommended releasing interim results for early reporting and these results are considered the final study results.
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 |
| Mar 20, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 28, 2022 | Mar 20, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D050397 | Radiotherapy, Intensity-Modulated |
| D001918 | Brachytherapy |
| D000726 | Androgen Antagonists |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Gleason 6+T2c-T4+PSA<50 |
|
| Gleason 6+T1c-T2b+PSA>20 |
|
| Brachytherapy (low or high dose rate) |
|
| 6 months (short term) |
|
| 32 months (long term) |
|
| Superiority |
|
|
|
|
|
|
| OG001 |
| Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
|
|
|
| OG001 | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
|
|
| Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) |
Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
|
|
| OG001 | Whole Pelvic Radiotherapy + ADT + Prostate Boost (Arm 2) | Participants receive ADT as in Arm 1. Approximately 8-10 weeks after starting the LHRH agent, participants undergo external beam radiation therapy (EBRT) to the whole pelvis-including prostate, seminal vesicles, and pelvic lymph nodes-delivered as 45 Gy in 25 fractions using three-dimensional conformal radiotherapy (3D CRT) or intensity modulated radiotherapy (IMRT). A boost is then administered as specified for Arm 1. |
|