Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

April 12, 2024 updated by: Radiation Therapy Oncology Group

A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Study Overview

Status

Active, not recruiting

Conditions

Prostate Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy.
To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy after radical prostatectomy.

Secondary

To compare secondary biochemical failure, the development of hormone-refractory disease , distant metastasis, cause-specific mortality, and overall mortality at five years.
To compare acute and late morbidity based on Common Toxicity Criteria for Adverse Effects (CTCAE), v. 3.0.
To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used.
To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms) patterns and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used.
To assess the degree, duration, and significant differences of disease-specific health-related quality of life (HRQOL) decrements among treatment arms.
To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP.
To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells for future translational research analyses.

Tertiary

To assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression).
To evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies.
To assess associations between serum levels of beta-amyloid and measures of cognition and mood and depression.
An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system.

OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no), prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs > 1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients are randomized to 1 of 3 treatment arms.

Follow-up occurs 3, 6, and 12 months after the completion of radiation therapy, then every 6 months for 6 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Actual)

1792

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre - Calgary
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute at University of Alberta
- New Brunswick
  - Saint John, New Brunswick, Canada, E2L 4L2
    - Saint John Regional Hospital
- Newfoundland and Labrador
  - Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Doctor H. Bliss Murphy Cancer Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Margaret and Charles Juravinski Cancer Centre
  - London, Ontario, Canada, N6A 4L6
    - London Regional Cancer Program at London Health Sciences Centre
  - Thunder Bay, Ontario, Canada, P7B 6V4
    - Cancer Care Program at Thunder Bay Regional Health Sciences
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - Maisonneuve-Rosemont Hospital
  - Montreal, Quebec, Canada, H2L 4M1
    - Hopital Notre-Dame du CHUM
  - Quebec City, Quebec, Canada, G1R 2J6
    - Centre Hospitalier Universitaire de Quebec
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - CHUS-Hopital Fleurimont
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Saskatoon Cancer Centre at the University of Saskatchewan
China
- - Hong Kong, China
    - Pamela Youde Nethersole Eastern Hospital
Israel
- - Petach Tikva, Israel, 49100
    - Rabin Medical Center - Beilinson Campus
  - Tel Aviv, Israel, 64239
    - Tel-Aviv Sourasky Medical Center
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Uab Comprehensive Cancer Center
- Alaska
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arizona
  - Peoria, Arizona, United States, 85381
    - Arizona Center for Cancer Care - Peoria
  - Phoenix, Arizona, United States, 85013
    - Arizona Oncology Services Foundation
  - Tucson, Arizona, United States, 85704
    - Arizona Oncology - Tucson
- California
  - Auburn, California, United States, 95603
    - Auburn Radiation Oncology
  - Burlingame, California, United States, 94010
    - Peninsula Medical Center
  - Cameron Park, California, United States, 95682
    - Radiation Oncology Centers - Cameron Park
  - Carmichael, California, United States, 95608
    - Mercy Cancer Center at Mercy San Juan Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants - Castro Valley
  - Chico, California, United States, 95926
    - Enloe Cancer Center at Enloe Medical Center
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Fremont, California, United States, 94538
    - Washington Township Hospital
  - Fresno, California, United States, 93720
    - Cancer Care Associates
  - Fresno, California, United States, 93720
    - California Cancer Center - Woodward Park Office
  - La Jolla, California, United States, 92093-0658
    - Rebecca and John Moores UCSD Cancer Center
  - Long Beach, California, United States, 90822
    - Veterans Affairs Medical Center - Long Beach
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Los Angeles, California, United States, 90048
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Mission Hills, California, United States, 91346-9600
    - Providence Holy Cross Cancer Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital Cancer Center
  - Novato, California, United States, 94945
    - Sutter Health - Western Division Cancer Research Group
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, United States, 94609
    - Tom K Lee, Incorporated
  - Orange, California, United States, 92868
    - St. Joseph Hospital Regional Cancer Center - Orange
  - Paradise, California, United States, 95969
    - Feather River Hospital Cancer Center
  - Roseville, California, United States, 95661
    - Radiation Oncology Center - Roseville
  - Sacramento, California, United States, 95815
    - Radiological Associates of Sacramento Medical Group, Incorporated
  - Sacramento, California, United States, 95819
    - Mercy General Hospital
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - Saint Helena, California, United States, 94574
    - Saint Helena Hospital
  - San Francisco, California, United States, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Pablo, California, United States, 94806
    - Doctors Medical Center - San Pablo Campus
  - Vacaville, California, United States, 95687
    - Solano Radiation Oncology Center
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers - Aurora
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center at UC Health Sciences Center
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital Cancer Center
  - New Britain, Connecticut, United States, 06050
    - George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
  - Norwich, Connecticut, United States, 06360
    - William W. Backus Hospital
- Delaware
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Washington Cancer Institute at Washington Hospital Center
- Florida
  - Gainesville, Florida, United States, 32610-0232
    - University of Florida Shands Cancer Center
  - Jacksonville, Florida, United States, 32207
    - Baptist Cancer Institute - Jacksonville
  - Jacksonville, Florida, United States, 32207
    - Integrated Community Oncology Network at Southside Cancer Center
  - Jacksonville, Florida, United States, 32258
    - Baptist Medical Center South
  - Jacksonville Beach, Florida, United States, 32250
    - Integrated Community Oncology Network
  - Miami, Florida, United States, 33176
    - Baptist-South Miami Regional Cancer Program
  - Orange Park, Florida, United States, 32073
    - Integrated Community Oncology Network - Orange Park
  - Orlando, Florida, United States, 32803-1273
    - Florida Hospital Cancer Institute at Florida Hospital Orlando
  - Palatka, Florida, United States, 32177
    - Florida Cancer Center - Palatka
  - Saint Augustine, Florida, United States, 32086
    - Flagler Cancer Center
  - Tampa, Florida, United States, 33612
    - Veterans Affairs Medical Center - Tampa
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute of Emory University
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30308
    - Emory Crawford Long Hospital
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Cumming, Georgia, United States, 30041
    - Northside Hospital-Forsyth
  - Fayetteville, Georgia, United States, 30214
    - Piedmont Fayette Hospital
  - Savannah, Georgia, United States, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Illinois
  - Chicago, Illinois, United States, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, United States, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Chicago, Illinois, United States, 60608
    - Mount Sinai Hospital Medical Center
  - Chicago, Illinois, United States, 60657
    - Creticos Cancer Center at Advocate Illinois Masonic Medical Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Freeport, Illinois, United States, 61032
    - Leonard C. Ferguson Cancer Center
  - Harvey, Illinois, United States, 60426
    - Ingalls Cancer Care Center at Ingalls Memorial Hospital
  - Hines, Illinois, United States, 60141
    - Veterans Affairs Medical Center - Hines
  - Maywood, Illinois, United States, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Moline, Illinois, United States, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Cancer Institute at St. John's Hospital
- Indiana
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Fort Wayne, Indiana, United States, 46805
    - Parkview Regional Cancer Center at Parkview Health
  - Fort Wayne, Indiana, United States, 46804
    - Radiation Oncology Associates Southwest
  - Goshen, Indiana, United States, 46526
    - Center for Cancer Care at Goshen General Hospital
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
- Iowa
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
- Kansas
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67214
    - Wesley Medical Center
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Lexington, Kentucky, United States, 40536-0093
    - Lucille P. Markey Cancer Center at University of Kentucky
  - Louisville, Kentucky, United States, 40207
    - Norton Suburban Hospital
- Louisiana
  - Alexandria, Louisiana, United States, 71315-3198
    - Tulane Cancer Center Office of Clinical Research
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center - Baton Rouge
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, United States, 70112
    - Medical Center of Louisiana - New Orleans
- Maryland
  - Baltimore, Maryland, United States, 21229
    - St. Agnes Hospital Cancer Center
  - Baltimore, Maryland, United States, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center Cancer Center
  - Columbia, Maryland, United States, 21044
    - Central Maryland Oncology Center
  - Glen Burnie, Maryland, United States, 21061
    - Tate Cancer Center at Baltimore Washington Medical Center
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston University Cancer Research Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Brigham and Women's Cancer Center
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
  - Fall River, Massachusetts, United States, 02721
    - Hudner Oncology Center at Saint Anne's Hospital - Fall River
  - Hyannis, Massachusetts, United States, 02601
    - Cape Cod Hospital
  - Lowell, Massachusetts, United States, 01854
    - Lowell General Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Clinton Township, Michigan, United States, 48038
    - Henry Ford Macomb Hospital
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48532
    - McLaren Cancer Institute
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - MeritCare Bemidji
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - St. Luke's Hospital Cancer Care Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Mankato, Minnesota, United States, 56002
    - Immanuel St. Joseph's
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology - Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology - Woodbury
- Mississippi
  - Pascagoula, Mississippi, United States, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Cancer Institute of Cape Girardeau, LLC
  - Saint Louis, Missouri, United States, 63141
    - Barnes-Jewish West County Hospital
  - Saint Louis, Missouri, United States, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
- Nebraska
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68114
    - Methodist Estabrook Cancer Center
  - Omaha, Nebraska, United States, 68130
    - Lakeside Hospital
  - Omaha, Nebraska, United States, 68198
    - Nebraska Medical Center
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Hampshire
  - Exeter, New Hampshire, United States, 03833
    - Center for Cancer Care at Exeter Hospital
  - Keene, New Hampshire, United States, 03431
    - Kingsbury Center for Cancer Care at Cheshire Medical Center
  - Lebanon, New Hampshire, United States, 03756-0002
    - Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan-Kettering Cancer Center - Basking Ridge
  - Galloway, New Jersey, United States, 08240
    - AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus
  - Marlton, New Jersey, United States, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - New Brunswick, New Jersey, United States, 08901
    - Saint Peter's University Hospital
  - New Brunswick, New Jersey, United States, 08903
    - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  - Pennington, New Jersey, United States, 08534
    - Capital Health Regional Cancer Center
  - Ridgewood, New Jersey, United States, 07450
    - Valley Hospital - Ridgewood
  - Somerville, New Jersey, United States, 08876
    - Somerset Medical Center
  - Sparta, New Jersey, United States, 07871
    - Frederick R. and Betty M. Smith Cancer Treatment Center
  - Vineland, New Jersey, United States, 08360
    - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
  - Voorhees, New Jersey, United States, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87109
    - New Mexico Cancer Center
  - Las Cruces, New Mexico, United States, 88011
    - University of New Mexico Cancer Center - South
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, PC at Albany Regional Cancer Care
  - Brooklyn, New York, United States, 11215
    - New York Methodist Hospital
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Canandaigua, New York, United States, 14424
    - Sands Cancer Center
  - Commack, New York, United States, 11725
    - Memorial Sloan-Kettering Cancer Center
  - New York, New York, United States, 10025
    - St. Luke's - Roosevelt Hospital Center - St.Luke's Division
  - New York, New York, United States, 10021
    - Stich Radiation Center at NewYork-Presbyterian Hospital/Weill Cornell Medical Center
  - Poughkeepsie, New York, United States, 12601
    - Hudson Valley Oncology Associates
  - Poughkeepsie, New York, United States, 12601-3990
    - Dyson Center for Cancer Care at Vassar Brothers Medical Center
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Rochester, New York, United States, 14620
    - Highland Hospital of Rochester
  - Rochester, New York, United States, 14621
    - Lipson Cancer and Blood Center at Rochester General Hospital
  - Rochester, New York, United States, 14626
    - University Radiation Oncology at Parkridge Hospital
  - Rockville Centre, New York, United States, 11570
    - Memorial Sloan-Kettering Cancer Center - Rockville Centre
  - Sleepy Hollow, New York, United States, 10591
    - Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203-5400
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28801
    - Mission Hospitals - Memorial Campus
  - Chapel Hill, North Carolina, United States, 27599-7295
    - Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  - Charlotte, North Carolina, United States, 28232-2861
    - Blumenthal Cancer Center at Carolinas Medical Center
  - Greensboro, North Carolina, United States, 27403-1198
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Morehead City, North Carolina, United States, 28557
    - Coleman Radiation Oncology Center at Carter General Hospital
  - New Bern, North Carolina, United States, 28560
    - CarolinaEast Cancer Care
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Raleigh, North Carolina, United States, 27607
    - Rex Cancer Center at Rex Hospital
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Cancer Center
  - Supply, North Carolina, United States, 28462
    - South Atlantic Radiation Oncology, LLC
  - Wilmington, North Carolina, United States, 28401
    - Zimmer Cancer Center at New Hanover Regional Medical Center
  - Wilmington, North Carolina, United States, 28401
    - Coastal Carolina Radiation Oncology Center
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, United States, 58102
    - MeritCare Broadway
  - Fargo, North Dakota, United States, 58122
    - Roger Maris Cancer Center at MeritCare Hospital
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center at Altru Hospital
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Akron, Ohio, United States, 44309-2090
    - Summa Center for Cancer Care at Akron City Hospital
  - Barberton, Ohio, United States, 44203
    - Barberton Citizens Hospital
  - Canton, Ohio, United States, 44710-1799
    - Aultman Cancer Center at Aultman Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44106-5065
    - Case Comprehensive Cancer Center
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center at Fairview Hospital
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Columbus, Ohio, United States, 43210-1240
    - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Mentor, Ohio, United States, 44060
    - Lake/University Ireland Cancer Center
  - Middleburg Heights, Ohio, United States, 44130
    - Southwest General Health Center
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Orange Village, Ohio, United States, 44122
    - UHHS Chagrin Highlands Medical Center
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Parma, Ohio, United States, 44129
    - Parma Community General Hospital
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center Cancer Center
  - Salem, Ohio, United States, 44460
    - Cancer Care Center, Incorporated
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Steubenville, Ohio, United States, 43952
    - Tony Teramana Cancer Center
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Foundation - Strongsville
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Westlake, Ohio, United States, 44145
    - UHHS Westlake Medical Center
  - Wooster, Ohio, United States, 44691
    - Cancer Treatment Center
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic - Wooster
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Oklahoma University Cancer Institute
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Oregon
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer Center - Eugene
  - Grants Pass, Oregon, United States, 97527
    - Three Rivers Community Hospital
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Medford, Oregon, United States, 97504
    - Dubs Cancer Center at Rogue Valley Medical Center
  - Medford, Oregon, United States, 97504
    - Providence Cancer Center at PMCC
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
  - Salem, Oregon, United States, 97309-5014
    - Salem Hospital Regional Cancer Care Services
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Rosenfeld Cancer Center at Abington Memorial Hospital
  - Beaver, Pennsylvania, United States, 15009
    - UPMC Cancer Center at Beaver Medical Center
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Cancer Network at St. Luke's Hospital
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Clairton, Pennsylvania, United States, 15025
    - UPMC Cancer Center at Jefferson Regional Medical Center
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Dunmore, Pennsylvania, United States, 18512
    - Northeast Radiation Oncology Center
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Center - Arnold Palmer Pavilion
  - Hershey, Pennsylvania, United States, 17033-0850
    - Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC Cancer Center at the John P. Murtha Pavilion
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster General Hospital
  - Langhorne, Pennsylvania, United States, 19047
    - St. Mary Regional Cancer Center
  - McKeesport, Pennsylvania, United States, 15132
    - UPMC Cancer Center at UPMC McKeesport
  - Milford, Pennsylvania, United States, 18337
    - Upper Delaware Valley Cancer Center
  - Monroeville, Pennsylvania, United States, 15146
    - Intercommunity Cancer Center
  - Moon, Pennsylvania, United States, 15108
    - UPMC - Moon
  - Natrona Heights, Pennsylvania, United States, 15065
    - Alle-Kiski Medical Center
  - Natrona Heights, Pennsylvania, United States, 15065
    - UPMC Cancer Center - Natrona Heights
  - New Castle, Pennsylvania, United States, 16105
    - Jameson Memorial Hospital - North Campus
  - Paoli, Pennsylvania, United States, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19111-2497
    - Fox Chase Cancer Center - Philadelphia
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Cancer Center
  - Philadelphia, Pennsylvania, United States, 19107-5541
    - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny Cancer Center at Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC Cancer Center at UPMC Presbyterian
  - Pittsburgh, Pennsylvania, United States, 15213-2582
    - UPMC - Shadyside
  - Pittsburgh, Pennsylvania, United States, 15213
    - UPMC Cancer Center at Magee-Womens Hospital
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC Cancer Center at UPMC St. Margaret
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC Cancer Center at UPMC Passavant
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC Cancer Center - Upper St. Clair
  - Reading, Pennsylvania, United States, 19605
    - St. Joseph Medical Center
  - Reading, Pennsylvania, United States, 19612-6052
    - McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
  - Washington, Pennsylvania, United States, 15301
    - Washington Hospital Cancer Center
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - Main Line Health
  - York, Pennsylvania, United States, 17405
    - York Cancer Center at Apple Hill Medical Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Charleston, South Carolina, United States, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, United States, 29615
    - Cancer Centers of the Carolinas - Eastside
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Faris Road
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Grove Commons
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Medical Oncology
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Radiation Oncology
  - Hilton Head Island, South Carolina, United States, 29926
    - Hilton Head Radiation Oncology Center
  - Seneca, South Carolina, United States, 29672
    - Cancer Centers of the Carolinas - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas - Spartanburg
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
- Tennessee
  - Jackson, Tennessee, United States, 38301
    - West Tennessee Cancer Center at Jackson-Madison County General Hospital
- Texas
  - Bedford, Texas, United States, 76022
    - Texas Oncology, PA at Harris Center HEB
  - Dallas, Texas, United States, 75390
    - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
  - Denton, Texas, United States, 76210
    - Texas Oncology, PA at Texas Cancer Center - Denton South
  - Fort Worth, Texas, United States, 76104
    - Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
  - Galveston, Texas, United States, 77555-0361
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77024
    - Memorial Hermann Hospital - Memorial City
  - Lewisville, Texas, United States, 75067
    - Texas Oncology, PA at Lake Vista Cancer Center
  - Longview, Texas, United States, 75601
    - Longview Cancer Center
  - San Antonio, Texas, United States, 78217
    - Cancer Care Centers of South Texas - Northeast
  - Sherman, Texas, United States, 75090
    - Texas Oncology, PA at Texas Cancer Center - Sherman
  - Sugar Land, Texas, United States, 77479
    - Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
  - Tyler, Texas, United States, 75702
    - Tyler Cancer Center
  - Wichita Falls, Texas, United States, 76310
    - Texas Oncology, PA - Wichita Falls
- Utah
  - Cedar City, Utah, United States, 84720
    - Sandra L. Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84157
    - Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute at University of Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Vermont
  - Burlington, Vermont, United States, 05401
    - Fletcher Allen Health Care - University Health Center Campus
  - Saint Johnsbury, Vermont, United States, 05819
    - Norris Cotton Cancer Center - North
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Inova Alexandria Hospital
  - Charlottesville, Virginia, United States, 22901
    - Martha Jefferson Hospital Cancer Care Center
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Norfolk, Virginia, United States, 23507
    - Sentara Cancer Institute at Sentara Norfolk General Hospital
  - Portsmouth, Virginia, United States, 23708-2197
    - Naval Medical Center - Portsmouth
  - Richmond, Virginia, United States, 23249
    - Veterans Affairs Medical Center - Richmond
  - Virginia Beach, Virginia, United States, 23454
    - Coastal Cancer Center at Sentara Virginia Beach General Hospital
- Washington
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Tacoma, Washington, United States, 98405-3004
    - Franciscan Cancer Center at St. Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Medical Center
  - Yakima, Washington, United States, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Health Sciences Center - Charleston
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Memorial Hospital
  - Appleton, Wisconsin, United States, 54911
    - Theda Care Cancer Institute
  - Appleton, Wisconsin, United States, 54911-3496
    - Fox Valley Hematology and Oncology - East Grant Street
  - Beloit, Wisconsin, United States, 53511
    - Beloit Memorial Hospital
  - Fond Du Lac, Wisconsin, United States, 54935
    - Central Wisconsin Cancer Program at Agnesian HealthCare
  - Green Bay, Wisconsin, United States, 54301
    - Bellin Memorial Hospital
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - La Crosse, Wisconsin, United States, 54601
    - Franciscan Skemp Healthcare - La Crosse Campus
  - Madison, Wisconsin, United States, 53792-6164
    - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Cancer Care Center at Bay Area Medical Center
  - Menomonee Falls, Wisconsin, United States, 53051
    - Community Memorial Hospital Cancer Care Center
  - Mequon, Wisconsin, United States, 53097
    - Columbia Saint Mary's Hospital - Ozaukee
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin Cancer Center
  - Milwaukee, Wisconsin, United States, 53295
    - Veterans Affairs Medical Center - Milwaukee
  - Milwaukee, Wisconsin, United States, 53215
    - Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53211
    - Columbia-Saint Mary's Water Tower Medical Commons
  - Mukwonago, Wisconsin, United States, 53149
    - D.N. Greenwald Center
  - Oconomowoc, Wisconsin, United States, 53066
    - Regional Cancer Center at Oconomowoc Memorial Hospital
  - Racine, Wisconsin, United States, 53405
    - All Saints Cancer Center at Wheaton Franciscan Healthcare
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Door County Cancer Center at Door County Memorial Hospital
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital Regional Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital
  - West Allis, Wisconsin, United States, 53227
    - West Allis Memorial Hospital
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Riverview UW Cancer Center at Riverview Hospital
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
• Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic or robotically assisted. There is no time limit for the date of radical prostatectomy.
A post-radical prostatectomy entry prostate-specific antigen (PSA) of ≥ 0.1 and < 2.0 ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of registration;
One of the following pathologic classifications:
- T3N0/Nx disease with or without a positive prostatectomy surgical margin; or
- T2N0/Nx disease with or without a positive prostatectomy surgical margin;
Prostatectomy Gleason score of 9 or less;
Zubrod Performance Status of 0-1;
Age ≥ 18;
No distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination (including digital rectal exam) within 8 weeks (60 days) prior to registration;
- A computerized tomography (CT) scan of the pelvis (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration;
- Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
Adequate bone marrow function, within 90 days prior to registration, defined as follows:
- Platelets ≥ 100,000 cells/mm^3 based upon compete blood count (CBC);
- Hemoglobin ≥ 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is recommended).
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x the upper limit of normal within 90 days prior to registration;
Serum total testosterone must be ≥ 40% of the lower limit of normal (LLN) of the assay used (testosterone ÷ LLN must be ≥ 0.40) within 90 days prior to registration (Note: Patients who have had a unilateral orchiectomy are eligible as long as this requirement is met);
Patients must sign a study-specific informed consent prior to study entry.

Exclusion Criteria:

A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration. Note: The use of finasteride or dutasteride (±tamsulosin) for longer periods prior to prostatectomy is acceptable;
Androgen deprivation therapy started after prostatectomy and prior to registration (Note: The use of finasteride or dutasteride (±tamsulosin) after prostatectomy is not acceptable - must be stopped within 3 months after prostatectomy. Androgen deprivation therapy must be stopped within 3 months after prostatectomy);
Neoadjuvant chemotherapy before or after prostatectomy;
Prior chemotherapy for any other disease site if given within 5 years prior to registration;
Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
Prior pelvic radiotherapy;
Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years [for example, carcinoma in situ of the oral cavity is permissible];
Severe, active co-morbidity, defined as follows:
- History of inflammatory bowel disease;
- History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; Note, however, that human immunodeficiency viruses (HIV) testing is not required for entry into this protocol. The need to exclude patients with acquired immunodeficiency syndrome (AIDS) from this protocol is necessary because the treatments involved in this protocol may result in increased toxicity and immunosuppression.
Prior allergic reaction to the study drug(s) involved in this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PBRT Alone Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.	Radiation: PBRT 1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required. Other Names: Three-Dimensional Conformal Radiation Therapy (3D-CRT) Prostate bed radiotherapy Intensity modulated RT (IMRT)
Experimental: PBRT + STAD Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).	Radiation: PBRT 1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required. Other Names: Three-Dimensional Conformal Radiation Therapy (3D-CRT) Prostate bed radiotherapy Intensity modulated RT (IMRT) Drug: AA Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day. Other Names: bicalutamide flutamide Drug: LHRH agonist Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection. Other Names: goserelin leuprolide buserelin triptorelin
Experimental: PLNRT + PBRT + STADT Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).	Radiation: PBRT 1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required. Other Names: Three-Dimensional Conformal Radiation Therapy (3D-CRT) Prostate bed radiotherapy Intensity modulated RT (IMRT) Drug: AA Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day. Other Names: bicalutamide flutamide Drug: LHRH agonist Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection. Other Names: goserelin leuprolide buserelin triptorelin Radiation: PLNRT 1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required. Other Names: Pelvic lymph node radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Free From Progression (FFP) at 5 Years Time Frame: From randomization to five years.	Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen [PSA] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.	From randomization to five years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure) Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.	From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease) Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.	From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Local Failure Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.	From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants With Distant Metastasis Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.	From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality) Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. [Biochemical progression is indicated by any rise in PSA.] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.	From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Alive (Overall Mortality) Time Frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.	From randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT) Time Frame: From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).	Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis.	From randomization to 90 days after completion of radiotherapy (approximately 7-8 weeks).
Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT) Time Frame: AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.	Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring > 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored.	AE: from 91 days after completion of RT (approximately 7-8 weeks) to last follow-up. Vital status: from randomization to last follow-up. Maximum follow-up at time of analysis was 10.5 years.
Comparison of Disease-specific Health Related Quality of Life (HRQOL) Change by the Expanded Prostate Cancer Index Composite (EPIC), Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test A & B, and Controlled Oral Word Association Test (COWAT) Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy.		From the 6th week of radiation therapy to 5 years post radiation therapy.
Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25) Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy.		From the 6th week of radiation therapy to 5 years post radiation therapy.
Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY) Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy.		From the 6th week of radiation therapy to 5 years post radiation therapy.
Evaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D) Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy.		From the 6th week of radiation therapy to 5 years post radiation therapy.
Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints Time Frame: Date of randomization to timepoint of the respective primary or secondary endpoint.		Date of randomization to timepoint of the respective primary or secondary endpoint.
Assessment of the Relationship(s) Between the American Urological Association Symptom Index (AUA SI) and Urinary Morbidity (Adverse Event Terms: Urinary Frequency/Urgency) Using the CTCAE v. 3.0 Grading System Time Frame: From the 6th week of radiation therapy to 5 years post radiation therapy.		From the 6th week of radiation therapy to 5 years post radiation therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

NRG Oncology

Cancer and Leukemia Group B

Investigators

Principal Investigator: Alan Pollack, MD, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Pollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, Wefel JS, Martin AG, Michalski JM, Angyalfi SJ, Lukka H, Faria SL, Rodrigues GB, Beauchemin MC, Lee RJ, Seaward SA, Allen AM, Monitto DC, Seiferheld W, Sartor O, Feng F, Sandler HM. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022 May 14;399(10338):1886-1901. doi: 10.1016/S0140-6736(21)01790-6.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

July 12, 2018

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimated)

December 5, 2007

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

RTOG-0534
CDR0000577574
NCI-2009-00733 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

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Detailed Description

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Phase

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How is the study designed?

Design Details

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Participant Group / Arm

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Primary Outcome Measures

Outcome Measure

Measure Description

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Secondary Outcome Measures

Outcome Measure

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Publications and helpful links

General Publications

Study record dates

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Study Start

Primary Completion (Actual)

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First Submitted

First Submitted That Met QC Criteria

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Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

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Clinical Trials on Prostate Cancer

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