- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368588
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- Demonstrate that prophylactic, neoadjuvant androgen-deprivation therapy (NADT) combined with whole-pelvic radiation therapy (WPRT) improves overall survival (OS) compared with NADT combined with prostate and seminal vesicle radiation therapy (RT), with both arms receiving a high-dose prostate boost delivered by intensity-modulated RT (IMRT), external-beam RT (EBRT), high-dose-rate (HDR) brachytherapy, or permanent prostate implant (PPI).
Secondary
- Demonstrate that prophylactic WPRT improves biochemical control.
- Determine the distant metastasis (DM)-free survival.
- Determine the cause-specific survival (CSS).
- Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT, P, and SV RT.
- Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT).
- Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (IL-1, IL-1ra, IL-6, tumor necrosis factor (TNF)-alpha, and C-reactive protein).
- Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
- Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.
- Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- BCCA-Cancer Centre for the Southern Interior
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Surrey, British Columbia, Canada, V3V 1Z2
- BCCA-Fraser Valley Cancer Centre
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Doctor H. Bliss Murphy Cancer Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
- QEII Health Sciences Centre/Nova Scotia Health Authority
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Ontario
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London, Ontario, Canada, N6A 4L6
- London Regional Cancer Program
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Newmarket, Ontario, Canada, L3Y 2P9
- Stronach Regional Health Centre at Southlake
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
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Montreal, Quebec, Canada, H3H 2R9
- The Research Institute of the McGill University Health Centre (MUHC)
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Montreal, Quebec, Canada, H2L 4M1
- CHUM - Hopital Notre-Dame
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Montreal, Quebec, Canada, H2W 1S6
- McGill University Department of Oncology
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Montreal, Quebec, Canada, H2X 3E4
- CHUM - Centre Hospitalier de l'Universite de Montreal
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Québec, Quebec, Canada, G1R 2J6
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Chai Wan, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Tel Litwinsky, Israel, 52621
- Chaim Sheba Medical Center
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Singapore, Singapore, 169610
- National Cancer Centre Singapore
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Singapore, Singapore, 119074
- National University Hospital Singapore
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Aarau, Switzerland, 5001
- Kantonsspital Aarau
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Alabama
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Mobile, Alabama, United States, 36688
- University of South Alabama Mitchell Cancer Institute
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Alaska
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Anchorage, Alaska, United States, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, United States, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, United States, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, United States, 99508
- Katmai Oncology Group
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Anchorage, Alaska, United States, 99508
- Providence Alaska Medical Center
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Fairbanks, Alaska, United States, 99701
- Fairbanks Memorial Hospital
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Arizona
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Gilbert, Arizona, United States, 85297
- Arizona Breast Cancer Specialists-Gilbert
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Peoria, Arizona, United States, 85381
- Arizona Center for Cancer Care-Peoria
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Phoenix, Arizona, United States, 85004
- Cancer Center at Saint Joseph's
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Phoenix, Arizona, United States, 85027
- Arizona Oncology-Deer Valley Center
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Phoenix, Arizona, United States, 85013
- Saint Joseph's Hospital and Medical Center
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Phoenix, Arizona, United States, 85027
- Arizona Breast Cancer Specialists-Phoenix
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Scottsdale, Arizona, United States, 85258
- Arizona Breast Cancer Specialists-Scottsdale
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Scottsdale, Arizona, United States, 85251
- Arizona Breast Cancer Specialists
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Scottsdale, Arizona, United States, 85260
- Arizona Oncology Services Foundation
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Scottsdale, Arizona, United States, 85251
- 21st Century Oncology-Scottsdale
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Surprise, Arizona, United States, 85374
- Arizona Center for Cancer Care-Surprise
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Tucson, Arizona, United States, 85704
- University of Arizona Cancer Center-Orange Grove Campus
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Tucson, Arizona, United States, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, United States, 85719
- University of Arizona Cancer Center-North Campus
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Tucson, Arizona, United States, 85704
- Arizona Oncology Associates-West Orange Grove
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Arkansas
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Hot Springs, Arkansas, United States, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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Jonesboro, Arkansas, United States, 72401
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Auburn, California, United States, 95603
- Sutter Cancer Centers Radiation Oncology Services-Auburn
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Bakersfield, California, United States, 93301
- AIS Cancer Center at San Joaquin Community Hospital
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Berkeley, California, United States, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Cameron Park, California, United States, 95682
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Carmichael, California, United States, 95608
- Mercy San Juan Medical Center
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Chico, California, United States, 95973
- Adventist Health Cancer Care Center Chico
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Fresno, California, United States, 93720
- Saint Agnes Medical Center
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Fresno, California, United States, 93720
- Fresno Cancer Center
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Greenbrae, California, United States, 94904
- Marin General Hospital
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La Jolla, California, United States, 92093
- UC San Diego Moores Cancer Center
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Long Beach, California, United States, 90822
- Tibor Rubin VA Medical Center
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Los Angeles, California, United States, 90033
- USC / Norris Comprehensive Cancer Center
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Los Angeles, California, United States, 90033
- Los Angeles County-USC Medical Center
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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Marysville, California, United States, 95901
- Fremont - Rideout Cancer Center
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Merced, California, United States, 95340
- Mercy UC Davis Cancer Center
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Modesto, California, United States, 95355
- Memorial Medical Center
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Oakland, California, United States, 94611
- Kaiser Permanente Oakland-Broadway
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Oakland, California, United States, 94609
- Alta Bates Summit Medical Center - Summit Campus
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Palm Springs, California, United States, 92262
- Desert Regional Medical Center
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Palo Alto, California, United States, 94304
- Stanford Cancer Institute Palo Alto
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Palo Alto, California, United States, 94301
- Palo Alto Medical Foundation Health Care
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Pomona, California, United States, 91767
- Pomona Valley Hospital Medical Center
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Rancho Cordova, California, United States, 95670
- Kaiser Permanente-Rancho Cordova Cancer Center
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Rohnert Park, California, United States, 94928
- Rohnert Park Cancer Center
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Roseville, California, United States, 95678
- The Permanente Medical Group-Roseville Radiation Oncology
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Roseville, California, United States, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
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Sacramento, California, United States, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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Sacramento, California, United States, 95823
- South Sacramento Cancer Center
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Sacramento, California, United States, 95816
- Mercy Cancer Center - Sacramento
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San Francisco, California, United States, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, United States, 94115
- UCSF Medical Center-Mount Zion
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San Jose, California, United States, 95128
- Santa Clara Valley Medical Center
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Santa Clara, California, United States, 95051
- Kaiser Permanente Medical Center - Santa Clara
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South San Francisco, California, United States, 94080
- Kaiser Permanente Cancer Treatment Center
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Stockton, California, United States, 95204
- Saint Joseph's Medical Center
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Sunnyvale, California, United States, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Truckee, California, United States, 96161
- Gene Upshaw Memorial Tahoe Forest Cancer Center
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Vacaville, California, United States, 95687
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers-Aurora
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Boulder, Colorado, United States, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, United States, 80909
- UCHealth Memorial Hospital Central
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Denver, Colorado, United States, 80210
- Porter Adventist Hospital
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Edwards, Colorado, United States, 81632
- Shaw Cancer Center
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Greeley, Colorado, United States, 80631
- North Colorado Medical Center
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Longmont, Colorado, United States, 80501
- Longmont United Hospital
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Loveland, Colorado, United States, 80539
- McKee Medical Center
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Parker, Colorado, United States, 80138
- Parker Adventist Hospital
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Connecticut
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Bridgeport, Connecticut, United States, 06606
- Hartford HealthCare - Saint Vincent's Medical Center
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Hartford, Connecticut, United States, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Middletown, Connecticut, United States, 06457
- Middlesex Hospital
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Delaware
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Newark, Delaware, United States, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, United States, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, United States, 19971
- Beebe Health Campus
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Seaford, Delaware, United States, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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District of Columbia
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Washington D.C., District of Columbia, United States, 20010
- Medstar Washington Hospital Center
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Florida
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Deerfield Beach, Florida, United States, 33064
- Broward Health North
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Jacksonville, Florida, United States, 32207
- Baptist MD Anderson Cancer Center
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Jacksonville, Florida, United States, 32258
- Baptist Medical Center South
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Jupiter, Florida, United States, 33458
- Jupiter Medical Center
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando, Florida, United States, 32806
- Orlando Health Cancer Institute
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Palatka, Florida, United States, 32177
- Cancer Center of Putnam
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Plantation, Florida, United States, 33324
- GenesisCare USA - Plantation
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Tampa, Florida, United States, 33612
- James A. Haley Veterans Affairs Hospital
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Trinity, Florida, United States, 34655
- Florida Cancer Affiliates
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Weston, Florida, United States, 33331
- Cleveland Clinic-Weston
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, United States, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, United States, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, United States, 30303
- Grady Health System
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Atlanta, Georgia, United States, 30309
- Piedmont Hospital
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Columbus, Georgia, United States, 31904
- John B Amos Cancer Center
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical Center
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Fayetteville, Georgia, United States, 30214
- Piedmont Fayette Hospital
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Gainesville, Georgia, United States, 30501
- Northeast Georgia Medical Center-Gainesville
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Macon, Georgia, United States, 31201
- Central Georgia Gynecologic Oncology
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Savannah, Georgia, United States, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Queen's Medical Center
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Honolulu, Hawaii, United States, 96817
- The Cancer Center of Hawaii-Liliha
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‘Aiea, Hawaii, United States, 96701
- The Cancer Center of Hawaii-Pali Momi
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Idaho
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Boise, Idaho, United States, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Coeur d'Alene, Idaho, United States, 83814
- Kootenai Health - Coeur d'Alene
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Meridian, Idaho, United States, 83642
- Idaho Urologic Institute-Meridian
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Post Falls, Idaho, United States, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, United States, 83864
- Kootenai Cancer Clinic
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Twin Falls, Idaho, United States, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Northwest Community Hospital
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Aurora, Illinois, United States, 60504
- Rush - Copley Medical Center
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60612
- John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, United States, 60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
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Chicago, Illinois, United States, 60640
- Weiss Memorial Hospital
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Chicago, Illinois, United States, 60657
- Advocate Illinois Masonic Medical Center
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Decatur, Illinois, United States, 62526
- Decatur Memorial Hospital
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Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
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Maywood, Illinois, United States, 60153
- Loyola University Medical Center
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Peoria, Illinois, United States, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, United States, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Rockford, Illinois, United States, 61114
- SwedishAmerican Regional Cancer Center/ACT
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Springfield, Illinois, United States, 62781
- Memorial Medical Center
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Springfield, Illinois, United States, 62702
- Saint John's Hospital
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Swansea, Illinois, United States, 62226
- Southwest Illinois Health Services LLP
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Urbana, Illinois, United States, 61801
- Carle Cancer Center
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Indiana
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Fort Wayne, Indiana, United States, 46805
- Parkview Hospital Randallia
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Fort Wayne, Indiana, United States, 46845
- Parkview Regional Medical Center
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Fort Wayne, Indiana, United States, 46804
- Radiation Oncology Associates PC
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Indianapolis, Indiana, United States, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Indianapolis, Indiana, United States, 46202
- IU Health Methodist Hospital
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South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
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Iowa
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Ames, Iowa, United States, 50010
- McFarland Clinic PC - Ames
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Cedar Rapids, Iowa, United States, 52403
- Mercy Hospital
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Cedar Rapids, Iowa, United States, 52402
- Saint Luke's Hospital
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Dubuque, Iowa, United States, 52001
- Finley Hospital
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Kansas
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Garden City, Kansas, United States, 67846
- Central Care Cancer Center - Garden City
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Garden City, Kansas, United States, 67846
- Saint Catherine Hospital
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Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
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Lawrence, Kansas, United States, 66044
- Lawrence Memorial Hospital
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Olathe, Kansas, United States, 66061
- Olathe Health Cancer Center
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Overland Park, Kansas, United States, 66210
- University of Kansas Cancer Center-Overland Park
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Topeka, Kansas, United States, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Wichita, Kansas, United States, 67214
- Ascension Via Christi Hospitals Wichita
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Owensboro, Kentucky, United States, 42303
- Owensboro Health Mitchell Memorial Cancer Center
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Mary Bird Perkins Cancer Center
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Covington, Louisiana, United States, 70433
- Mary Bird Perkins Cancer Center - Covington
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Houma, Louisiana, United States, 70360
- Mary Bird Perkins Cancer Center - Houma
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Metairie, Louisiana, United States, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, United States, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
-
New Orleans, Louisiana, United States, 70115
- Touro Infirmary
-
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Maryland
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Annapolis, Maryland, United States, 21401
- Anne Arundel Medical Center
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Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center
-
Baltimore, Maryland, United States, 21201
- University of Maryland/Greenebaum Cancer Center
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Baltimore, Maryland, United States, 21229
- Saint Agnes Hospital
-
Bel Air, Maryland, United States, 21014
- UM Upper Chesapeake Medical Center
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Columbia, Maryland, United States, 21044
- Central Maryland Radiation Oncology in Howard County
-
Elkton, Maryland, United States, 21921
- University of Maryland Radiation Oncology Center at Union Hospital
-
Glen Burnie, Maryland, United States, 21061
- UM Baltimore Washington Medical Center/Tate Cancer Center
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Salisbury, Maryland, United States, 21801
- TidalHealth Peninsula Regional
-
Towson, Maryland, United States, 21204
- UM Saint Joseph Medical Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Fall River, Massachusetts, United States, 02721
- Saint Anne's Hospital
-
Hyannis, Massachusetts, United States, 02601
- Cape Cod Hospital
-
Lowell, Massachusetts, United States, 01854
- Lowell General Hospital
-
Plymouth, Massachusetts, United States, 02360
- Beth Israel Deaconess Hospital-Plymouth
-
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Michigan
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Adrian, Michigan, United States, 49221
- Bixby Medical Center
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
-
Ann Arbor, Michigan, United States, 48106
- Saint Joseph Mercy Hospital
-
Ann Arbor, Michigan, United States, 48105
- Veteran's Administration Medical Center - Ann Arbor
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Bay City, Michigan, United States, 48706
- McLaren Cancer Institute-Bay City
-
Brownstown, Michigan, United States, 48183
- Henry Ford Cancer Institute-Downriver
-
Clarkston, Michigan, United States, 48346
- McLaren Cancer Institute-Clarkston
-
Clarkston, Michigan, United States, 48346
- GenesisCare USA - Clarkston
-
Clinton Township, Michigan, United States, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn, Michigan, United States, 48124
- Beaumont Hospital - Dearborn
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, United States, 48236
- Ascension Saint John Hospital
-
Farmington Hills, Michigan, United States, 48334
- Weisberg Cancer Treatment Center
-
Farmington Hills, Michigan, United States, 48336
- Beaumont Hospital - Farmington Hills
-
Farmington Hills, Michigan, United States, 48334
- GenesisCare USA - Farmington Hills
-
Flint, Michigan, United States, 48532
- McLaren Cancer Institute-Flint
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
-
Grand Rapids, Michigan, United States, 49503
- Mercy Health Saint Mary's
-
Kalamazoo, Michigan, United States, 49007
- West Michigan Cancer Center
-
Lansing, Michigan, United States, 48912
- Sparrow Hospital
-
Lansing, Michigan, United States, 48910
- Karmanos Cancer Institute at McLaren Greater Lansing
-
Lapeer, Michigan, United States, 48446
- McLaren Cancer Institute-Lapeer Region
-
Livonia, Michigan, United States, 48154
- Saint Mary Mercy Hospital
-
Mount Clemens, Michigan, United States, 48043
- McLaren Cancer Institute-Macomb
-
Mount Pleasant, Michigan, United States, 48858
- McLaren Cancer Institute-Central Michigan
-
Muskegon, Michigan, United States, 49444
- Mercy Health Mercy Campus
-
Owosso, Michigan, United States, 48867
- McLaren Cancer Institute-Owosso
-
Petoskey, Michigan, United States, 49770
- McLaren Cancer Institute-Northern Michigan
-
Pontiac, Michigan, United States, 48341
- Saint Joseph Mercy Oakland
-
Pontiac, Michigan, United States, 48341
- 21st Century Oncology-Pontiac
-
Port Huron, Michigan, United States, 48060
- McLaren-Port Huron
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital-Royal Oak
-
Saginaw, Michigan, United States, 48601
- Ascension Saint Mary's Hospital
-
Saint Joseph, Michigan, United States, 49085
- Lakeland Medical Center Saint Joseph
-
Troy, Michigan, United States, 48085
- William Beaumont Hospital - Troy
-
Troy, Michigan, United States, 48098
- GenesisCare USA - Troy
-
Warren, Michigan, United States, 48093
- Saint John Macomb-Oakland Hospital
-
West Bloomfield, Michigan, United States, 48322
- Henry Ford West Bloomfield Hospital
-
Wyoming, Michigan, United States, 49519
- Metro Health Hospital
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Minnesota
-
Albert Lea, Minnesota, United States, 56007
- Mayo Clinic Health System in Albert Lea
-
Bemidji, Minnesota, United States, 56601
- Sanford Joe Lueken Cancer Center
-
Duluth, Minnesota, United States, 55805
- Saint Luke's Hospital of Duluth
-
Mankato, Minnesota, United States, 56001
- Mayo Clinic Health Systems-Mankato
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
Monticello, Minnesota, United States, 55362
- Monticello Cancer Center
-
Saint Cloud, Minnesota, United States, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, United States, 55101
- Regions Hospital
-
Willmar, Minnesota, United States, 56201
- Rice Memorial Hospital
-
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Mississippi
-
Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
-
Pascagoula, Mississippi, United States, 39581
- Singing River Hospital
-
-
Missouri
-
Cape Girardeau, Missouri, United States, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, United States, 63703
- Southeast Cancer Center
-
City of Saint Peters, Missouri, United States, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, United States, 63141
- Siteman Cancer Center at West County Hospital
-
Joplin, Missouri, United States, 64804
- Freeman Health System
-
Kansas City, Missouri, United States, 64128
- Kansas City Veterans Affairs Medical Center
-
Kansas City, Missouri, United States, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, United States, 64116
- North Kansas City Hospital
-
Kansas City, Missouri, United States, 64131
- The University of Kansas Cancer Center-South
-
Lee's Summit, Missouri, United States, 64064
- University of Kansas Cancer Center - Lee's Summit
-
Rolla, Missouri, United States, 65401
- Delbert Day Cancer Institute at PCRMC
-
Saint Joseph, Missouri, United States, 64506
- Heartland Regional Medical Center
-
Springfield, Missouri, United States, 65807
- CoxHealth South Hospital
-
St Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
St Louis, Missouri, United States, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, United States, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, United States, 63125
- Veteran's Affairs Medical Center - Saint Louis
-
-
Montana
-
Billings, Montana, United States, 59101
- Billings Clinic Cancer Center
-
Great Falls, Montana, United States, 59405
- Benefis Healthcare- Sletten Cancer Institute
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, United States, 68124
- Alegent Health Bergan Mercy Medical Center
-
-
Nevada
-
Reno, Nevada, United States, 89502
- Renown Regional Medical Center
-
-
New Hampshire
-
Exeter, New Hampshire, United States, 03833
- Exeter Hospital
-
Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
-
-
New Jersey
-
Egg Harbor, New Jersey, United States, 08234
- AtlantiCare Surgery Center
-
Mount Holly, New Jersey, United States, 08060
- Virtua Memorial
-
Mullica Hill, New Jersey, United States, 08062
- Inspira Medical Center Mullica Hill
-
Plainsboro, New Jersey, United States, 08536
- Penn Medicine Princeton Health
-
Sewell, New Jersey, United States, 08080
- Sidney Kimmel Cancer Center Washington Township
-
Somerville, New Jersey, United States, 08876
- Robert Wood Johnson University Hospital Somerset
-
Sparta, New Jersey, United States, 07871
- Sparta Cancer Treatment Center
-
Vineland, New Jersey, United States, 08360
- Inspira Medical Center Vineland
-
Voorhees Township, New Jersey, United States, 08043
- Virtua Voorhees
-
-
New Mexico
-
Las Cruces, New Mexico, United States, 88011
- Memorial Medical Center - Las Cruces
-
-
New York
-
Bay Shore, New York, United States, 11706
- South Shore University Hospital
-
Brooklyn, New York, United States, 11215
- New York-Presbyterian/Brooklyn Methodist Hospital
-
Canandiaqua, New York, United States, 14424
- Sands Cancer Center
-
Cooperstown, New York, United States, 13326
- Mary Imogene Bassett Hospital
-
Elmira, New York, United States, 14905
- Arnot Ogden Medical Center/Falck Cancer Center
-
Lake Success, New York, United States, 11042
- Northwell Health/Center for Advanced Medicine
-
New Hyde Park, New York, United States, 11040
- Long Island Jewish Medical Center
-
New York, New York, United States, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
Rochester, New York, United States, 14642
- University of Rochester
-
Rochester, New York, United States, 14620
- Highland Hospital
-
Rochester, New York, United States, 14606
- Wilmot Cancer Institute Radiation Oncology at Greece
-
Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, United States, 10468
- James J Peters VA Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Durham, North Carolina, United States, 27710
- Duke University Medical Center
-
Durham, North Carolina, United States, 27705
- Durham VA Medical Center
-
Morehead City, North Carolina, United States, 28557
- The Coleman Radiation Center-Carteret General Hospital
-
Pinehurst, North Carolina, United States, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Raleigh, North Carolina, United States, 27607
- UNC REX Cancer Center
-
Supply, North Carolina, United States, 28462
- NHRMC Radiation Oncology - Supply
-
Wilmington, North Carolina, United States, 28401
- NHRMC Radiation Oncology - 16th Street
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
-
Winston-Salem, North Carolina, United States, 27103
- Novant Health Forsyth Medical Center
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- Sanford Broadway Medical Center
-
-
Ohio
-
Akron, Ohio, United States, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, United States, 44304
- Summa Health System - Akron Campus
-
Barberton, Ohio, United States, 44203
- Summa Health System - Barberton Campus
-
Beachwood, Ohio, United States, 44122
- UHHS-Chagrin Highlands Medical Center
-
Canton, Ohio, United States, 44708
- Cleveland Clinic Mercy Hospital
-
Chardon, Ohio, United States, 44024
- Geauga Hospital
-
Chillicothe, Ohio, United States, 45601
- Adena Regional Medical Center
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, United States, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Elyria, Ohio, United States, 44035
- Mercy Cancer Center-Elyria
-
Independence, Ohio, United States, 44131
- Cleveland Clinic Cancer Center Independence
-
Mansfield, Ohio, United States, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Maumee, Ohio, United States, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Mayfield Heights, Ohio, United States, 44124
- Hillcrest Hospital Cancer Center
-
Medina, Ohio, United States, 44256
- Summa Health Medina Medical Center
-
Mentor, Ohio, United States, 44060
- UH Seidman Cancer Center at Lake Health Mentor Campus
-
Middleburg Heights, Ohio, United States, 44130
- UH Seidman Cancer Center at Southwest General Hospital
-
Oregon, Ohio, United States, 43616
- Saint Charles Hospital
-
Parma, Ohio, United States, 44129
- University Hospitals Parma Medical Center
-
Portsmouth, Ohio, United States, 45662
- Southern Ohio Medical Center
-
Ravenna, Ohio, United States, 44266
- University Hospitals Portage Medical Center
-
Salem, Ohio, United States, 44460
- UH Seidman Cancer Center at Salem Regional Medical Center
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care
-
Sandusky, Ohio, United States, 44870
- UH Seidman Cancer Center at Firelands Regional Medical Center
-
Strongsville, Ohio, United States, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Sylvania, Ohio, United States, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, United States, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, United States, 43614
- University of Toledo
-
Westlake, Ohio, United States, 44145
- UHHS-Westlake Medical Center
-
Wooster, Ohio, United States, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
Wooster, Ohio, United States, 44691
- Cancer Treatment Center
-
Wpafb, Ohio, United States, 45433
- Wright-Patterson Medical Center
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
Tulsa, Oklahoma, United States, 74104
- Saint John Medical Center
-
-
Oregon
-
Clackamas, Oregon, United States, 97015
- Clackamas Radiation Oncology Center
-
Grants Pass, Oregon, United States, 97527
- Three Rivers Community Hospital
-
Medford, Oregon, United States, 97504
- Providence Medford Medical Center
-
Medford, Oregon, United States, 97504
- Rogue Valley Medical Center
-
Portland, Oregon, United States, 97213
- Providence Portland Medical Center
-
Portland, Oregon, United States, 97225
- Providence Saint Vincent Medical Center
-
Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest
-
-
Pennsylvania
-
Abington, Pennsylvania, United States, 19001
- Jefferson Abington Hospital
-
Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
Dunmore, Pennsylvania, United States, 18512
- Northeast Radiation Oncology Center
-
Ephrata, Pennsylvania, United States, 17522
- Ephrata Cancer Center
-
Furlong, Pennsylvania, United States, 18925
- Fox Chase Cancer Center Buckingham
-
Gettysburg, Pennsylvania, United States, 17325
- Adams Cancer Center
-
Hanover, Pennsylvania, United States, 17331
- Cherry Tree Cancer Center
-
Hershey, Pennsylvania, United States, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Lebanon, Pennsylvania, United States, 17042
- Sechler Family Cancer Center
-
Milford, Pennsylvania, United States, 18337
- Upper Delaware Valley Cancer Center
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System
-
West Reading, Pennsylvania, United States, 19611
- Reading Hospital
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Willow Grove, Pennsylvania, United States, 19090
- Asplundh Cancer Pavilion
-
York, Pennsylvania, United States, 17403
- WellSpan Health-York Hospital
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Health Cancer Center
-
Boiling Springs, South Carolina, United States, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
Georgetown, South Carolina, United States, 29440
- Tidelands Georgetown Memorial Hospital
-
Greenville, South Carolina, United States, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, United States, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, United States, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenwood, South Carolina, United States, 29646
- Self Regional Healthcare
-
Greer, South Carolina, United States, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, United States, 29651
- Gibbs Cancer Center-Pelham
-
Hilton Head Island, South Carolina, United States, 29926
- The Radiation Oncology Center-Hilton Head/Bluffton
-
Seneca, South Carolina, United States, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, United States, 29303
- Spartanburg Medical Center
-
-
South Dakota
-
Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37403
- Erlanger Medical Center
-
Kingsport, Tennessee, United States, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
-
-
Texas
-
Abilene, Texas, United States, 79606
- Texas Cancer Center
-
Beaumont, Texas, United States, 77702
- Texas Oncology PA Beaumont
-
Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Denison, Texas, United States, 75020
- Texas Oncology - Denison Cancer Center
-
Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
-
Fort Worth, Texas, United States, 76104
- Texas Oncology - Fort Worth Cancer Center
-
Galveston, Texas, United States, 77555-0565
- University of Texas Medical Branch
-
Houston, Texas, United States, 77030
- Ben Taub General Hospital
-
Houston, Texas, United States, 77024
- Memorial Hermann Memorial City Medical Center
-
League City, Texas, United States, 77573
- UTMB Cancer Center at Victory Lakes
-
McAllen, Texas, United States, 78503
- Texas Oncology-McAllen
-
McKinney, Texas, United States, 75071
- Texas Oncology-McKinney
-
Odessa, Texas, United States, 79761
- West Texas Cancer Center
-
Plano, Texas, United States, 75093
- Texas Oncology-Plano West
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
-
Sugar Land, Texas, United States, 77479
- Texas Oncology Cancer Center Sugar Land
-
Webster, Texas, United States, 77598
- Deke Slayton Cancer Center
-
-
Utah
-
American Fork, Utah, United States, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, United States, 84720
- Sandra L Maxwell Cancer Center
-
Murray, Utah, United States, 84107
- Intermountain Medical Center
-
Ogden, Utah, United States, 84403
- McKay-Dee Hospital Center
-
Ogden, Utah, United States, 84405
- Ogden Regional Medical Center
-
Provo, Utah, United States, 84604
- Utah Valley Regional Medical Center
-
Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, United States, 84106
- Utah Cancer Specialists-Salt Lake City
-
St. George, Utah, United States, 84770
- Dixie Medical Center Regional Cancer Center
-
-
Vermont
-
Bennington, Vermont, United States, 05201
- Southwestern Vermont Medical Center
-
Berlin Corners, Vermont, United States, 05602
- Central Vermont Medical Center/National Life Cancer Treatment
-
Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
-
Saint Johnsbury, Vermont, United States, 05819
- Norris Cotton Cancer Center-North
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia Cancer Center
-
Fishersville, Virginia, United States, 22939
- Augusta Health Center for Cancer and Blood Disorders
-
Hampton, Virginia, United States, 23666
- Sentara Cancer Institute at Sentara CarePlex Hospital
-
Harrisonburg, Virginia, United States, 22801
- Sentara Rockingham Memorial Hospital Hahn Cancer Center
-
Norfolk, Virginia, United States, 23507
- Sentara Norfolk General Hospital
-
Norfolk, Virginia, United States, 23505
- Bon Secours DePaul Medical Center
-
Portsmouth, Virginia, United States, 23708-2197
- Naval Medical Center - Portsmouth
-
Richmond, Virginia, United States, 23249
- Hunter Holmes McGuire Veterans Administration Medical Center
-
Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia
-
Suffolk, Virginia, United States, 23434
- Sentara Obici Hospital
-
Virginia Beach, Virginia, United States, 23454
- Sentara Virginia Beach General Hospital
-
-
Washington
-
Federal Way, Washington, United States, 98003
- Saint Francis Hospital
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
-
Vancouver, Washington, United States, 98664
- PeaceHealth Southwest Medical Center
-
Yakima, Washington, United States, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
-
West Virginia
-
Bridgeport, West Virginia, United States, 26330
- United Hospital Center
-
Morgantown, West Virginia, United States, 26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Antigo, Wisconsin, United States, 54409
- Langlade Hospital and Cancer Center
-
Appleton, Wisconsin, United States, 54911
- ThedaCare Regional Cancer Center
-
Appleton, Wisconsin, United States, 54911
- ThedaCare Regional Medical Center - Appleton
-
Brookfield, Wisconsin, United States, 53045
- Ascension Southeast Wisconsin Hospital - Elmbrook Campus
-
Eau Claire, Wisconsin, United States, 54701
- Marshfield Medical Center-EC Cancer Center
-
Eau Claire, Wisconsin, United States, 54703
- Mayo Clinic Health System Eau Claire Hospital-Luther Campus
-
Franklin, Wisconsin, United States, 53132
- Ascension Saint Francis - Reiman Cancer Center
-
Green Bay, Wisconsin, United States, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, United States, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Johnson Creek, Wisconsin, United States, 53038
- UW Cancer Center Johnson Creek
-
La Crosse, Wisconsin, United States, 54601
- Gundersen Lutheran Medical Center
-
La Crosse, Wisconsin, United States, 54601
- Mayo Clinic Health System-Franciscan Healthcare
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
-
Marinette, Wisconsin, United States, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marinette, Wisconsin, United States, 54143
- Bay Area Medical Center
-
Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, United States, 53051
- Froedtert Menomonee Falls Hospital
-
Mequon, Wisconsin, United States, 53097
- Ascension Columbia Saint Mary's Hospital Ozaukee
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, United States, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, United States, 53210
- Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
-
Milwaukee, Wisconsin, United States, 53211
- Ascension Columbia Saint Mary's Hospital - Milwaukee
-
Milwaukee, Wisconsin, United States, 53295
- Zablocki Veterans Administration Medical Center
-
Minocqua, Wisconsin, United States, 54548
- Marshfield Clinic-Minocqua Center
-
Oshkosh, Wisconsin, United States, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, United States, 53405
- Ascension All Saints Hospital
-
Rice Lake, Wisconsin, United States, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, United States, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sheboygan, Wisconsin, United States, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, United States, 54482
- Marshfield Clinic Stevens Point Center
-
Sturgeon Bay, Wisconsin, United States, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, United States, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, United States, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Wausau, Wisconsin, United States, 54401
- Aspirus Regional Cancer Center
-
West Allis, Wisconsin, United States, 53227
- Aurora West Allis Medical Center
-
West Bend, Wisconsin, United States, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Wisconsin Rapids, Wisconsin, United States, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
-
Wyoming
-
Cody, Wyoming, United States, 82414
- Billings Clinic-Cody
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
- History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
- Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration.
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.
- Zubrod Performance Status 0-1(unless otherwise specified);
- Age ≥ 18;
- CBC/differential obtained within 60 days prior to registration on study, with adequate bone marrow function defined as follows:
- 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.);
- Patient must be able to provide study specific informed consent prior to study entry.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
Daily fractions
Daily fractions
Implant
Tablet
Injection
|
|
Experimental: 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.
|
Daily fractions
Daily fractions
Implant
Tablet
Injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Alive (Overall Survival)
Time Frame: 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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of Participants Who Died Due to Prostate Cancer
Time Frame: 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.
|
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.
|
|
Percentage of Participants With Distant Metastasis
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
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
Time Frame: Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique.
|
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.
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Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique.
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EPIC-26 Urinary Irritative/Obstructive Subscore Change From Baseline at 6 Months
Time Frame: Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique.
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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.
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Baseline and 6 months after the end of RT, approximately 19-22 weeks, depending on boost technique.
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PROMIS Fatigue Score Change From Baseline Line at Last Week of Radiation Treatment
Time Frame: Baseline and last week of radiation treatment, approximately 19-22 weeks, depending on boost technique.
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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.
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Baseline and last week of radiation treatment, approximately 19-22 weeks, depending on boost technique.
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Quality Adjusted Life Years (QALYs)
Time Frame: 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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mack Roach, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Pituitary Hormone-Releasing Hormones
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Oligopeptides
- Nerve Tissue Proteins
- Proteins
- Therapeutics
- Pharmacologic Actions
- Chemical Actions and Uses
- Radiotherapy
- Radiotherapy, Computer-Assisted
- Androgen Antagonists
- Gonadotropin-Releasing Hormone
- Radiotherapy, Intensity-Modulated
- Brachytherapy
- Radiotherapy, Conformal
Other Study ID Numbers
- RTOG-0924
- CDR0000701128
- NCI-2011-02674 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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