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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00567580
• Other study ID #: RTOG-0534
• Secondary ID: CDR0000577574NCI
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2008

Study information

• Verified date: May 2024
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT01312974

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1792
• Est. primary completion date: July 12, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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;

3. 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;

4. Prostatectomy Gleason score of 9 or less;

5. Zubrod Performance Status of 0-1;

6. Age = 18;

7. 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.

8. 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).

9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x the upper limit of normal within 90 days prior to registration;

10. 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);

11. Patients must sign a study-specific informed consent prior to study entry.

Exclusion Criteria:

1. A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;

2. 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;

3. 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;

4. 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);

5. Neoadjuvant chemotherapy before or after prostatectomy;

6. Prior chemotherapy for any other disease site if given within 5 years prior to registration;

7. Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;

8. Prior pelvic radiotherapy;

9. 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];

10. 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.

11. Prior allergic reaction to the study drug(s) involved in this protocol.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• PBRT
1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.
• PLNRT
1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.

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.
• 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.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre at Pasqua Hospital	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Doctor H. Bliss Murphy Cancer Centre	Saint John's	Newfoundland and Labrador
Canada	Saskatoon Cancer Centre at the University of Saskatchewan	Saskatoon	Saskatchewan
Canada	CHUS-Hopital Fleurimont	Sherbrooke	Quebec
Canada	Cancer Care Program at Thunder Bay Regional Health Sciences	Thunder Bay	Ontario
China	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Israel	Rabin Medical Center - Beilinson Campus	Petach Tikva
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
United States	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Summa Center for Cancer Care at Akron City Hospital	Akron	Ohio
United States	New York Oncology Hematology, PC at Albany Regional Cancer Care	Albany	New York
United States	New Mexico Cancer Center	Albuquerque	New Mexico
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	INOVA Alexandria Hospital	Alexandria	Virginia
United States	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana
United States	AnMed Cancer Center	Anderson	South Carolina
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Langlade Memorial Hospital	Antigo	Wisconsin
United States	Fox Valley Hematology and Oncology - East Grant Street	Appleton	Wisconsin
United States	Theda Care Cancer Institute	Appleton	Wisconsin
United States	Randolph Hospital	Asheboro	North Carolina
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Northside Hospital Cancer Center	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Auburn Radiation Oncology	Auburn	California
United States	Aurora Presbyterian Hospital	Aurora	Colorado
United States	Rocky Mountain Cancer Centers - Aurora	Aurora	Colorado
United States	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado
United States	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	St. Agnes Hospital Cancer Center	Baltimore	Maryland
United States	Barberton Citizens Hospital	Barberton	Ohio
United States	Memorial Sloan-Kettering Cancer Center - Basking Ridge	Basking Ridge	New Jersey
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	UPMC Cancer Center at Beaver Medical Center	Beaver	Pennsylvania
United States	Texas Oncology, PA at Harris Center HEB	Bedford	Texas
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Beloit Memorial Hospital	Beloit	Wisconsin
United States	MeritCare Bemidji	Bemidji	Minnesota
United States	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Billings Clinic - Downtown	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	UAB Comprehensive Cancer Center	Birmingham	Alabama
United States	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston University Cancer Research Center	Boston	Massachusetts
United States	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Boulder Community Hospital	Boulder	Colorado
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	New York Methodist Hospital	Brooklyn	New York
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Peninsula Medical Center	Burlingame	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Fairview Ridges Hospital	Burnsville	Minnesota
United States	Radiation Oncology Centers - Cameron Park	Cameron Park	California
United States	Sands Cancer Center	Canandaigua	New York
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	Cancer Institute of Cape Girardeau, LLC	Cape Girardeau	Missouri
United States	Mercy Cancer Center at Mercy San Juan Medical Center	Carmichael	California
United States	Rocky Mountain Oncology	Casper	Wyoming
United States	East Bay Radiation Oncology Center	Castro Valley	California
United States	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California
United States	Sandra L. Maxwell Cancer Center	Cedar City	Utah
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Martha Jefferson Hospital Cancer Care Center	Charlottesville	Virginia
United States	Creticos Cancer Center at Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Mount Sinai Hospital Medical Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Enloe Cancer Center at Enloe Medical Center	Chico	California
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	UPMC Cancer Center at Jefferson Regional Medical Center	Clairton	Pennsylvania
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Henry Ford Macomb Hospital	Clinton Township	Michigan
United States	Central Maryland Oncology Center	Columbia	Maryland
United States	Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Doctors Hospital at Ohio Health	Columbus	Ohio
United States	Grant Medical Center Cancer Care	Columbus	Ohio
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Mount Carmel Health - West Hospital	Columbus	Ohio
United States	Riverside Methodist Hospital Cancer Care	Columbus	Ohio
United States	Memorial Sloan-Kettering Cancer Center	Commack	New York
United States	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota
United States	Northside Hospital-Forsyth	Cumming	Georgia
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Danville Regional Medical Center	Danville	Virginia
United States	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania
United States	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois
United States	Grady Memorial Hospital	Delaware	Ohio
United States	Texas Oncology, PA at Texas Cancer Center - Denton South	Denton	Texas
United States	Porter Adventist Hospital	Denver	Colorado
United States	Presbyterian - St. Luke's Medical Center	Denver	Colorado
United States	St. Anthony Central Hospital	Denver	Colorado
United States	St. Joseph Hospital	Denver	Colorado
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa
United States	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa
United States	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	St. Luke's Hospital Cancer Care Center	Duluth	Minnesota
United States	Northeast Radiation Oncology Center	Dunmore	Pennsylvania
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Community Cancer Center	Elyria	Ohio
United States	Hematology Oncology Center	Elyria	Ohio
United States	Swedish Medical Center	Englewood	Colorado
United States	Willamette Valley Cancer Center - Eugene	Eugene	Oregon
United States	Center for Cancer Care at Exeter Hospital	Exeter	New Hampshire
United States	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska
United States	Hudner Oncology Center at Saint Anne's Hospital - Fall River	Fall River	Massachusetts
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	MeritCare Broadway	Fargo	North Dakota
United States	Roger Maris Cancer Center at MeritCare Hospital	Fargo	North Dakota
United States	Piedmont Fayette Hospital	Fayetteville	Georgia
United States	St. Francis Hospital	Federal Way	Washington
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Cancer Institute	Flint	Michigan
United States	Central Wisconsin Cancer Program at Agnesian HealthCare	Fond Du Lac	Wisconsin
United States	Parkview Regional Cancer Center at Parkview Health	Fort Wayne	Indiana
United States	Radiation Oncology Associates Southwest	Fort Wayne	Indiana
United States	Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital	Fort Worth	Texas
United States	Leonard C. Ferguson Cancer Center	Freeport	Illinois
United States	Valley Medical Oncology	Fremont	California
United States	Washington Township Hospital	Fremont	California
United States	California Cancer Center - Woodward Park Office	Fresno	California
United States	Cancer Care Associates	Fresno	California
United States	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus	Galloway	New Jersey
United States	University of Texas Medical Branch	Galveston	Texas
United States	Adams Cancer Center	Gettysburg	Pennsylvania
United States	Tate Cancer Center at Baltimore Washington Medical Center	Glen Burnie	Maryland
United States	Center for Cancer Care at Goshen General Hospital	Goshen	Indiana
United States	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota
United States	Three Rivers Community Hospital	Grants Pass	Oregon
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	North Colorado Medical Center	Greeley	Colorado
United States	Bellin Memorial Hospital	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina
United States	UPMC Cancer Center - Arnold Palmer Pavilion	Greensburg	Pennsylvania
United States	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina
United States	Cancer Centers of the Carolinas - Greer Radiation Oncology	Greer	South Carolina
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Hilton Head Radiation Oncology Center	Hilton Head Island	South Carolina
United States	Veterans Affairs Medical Center - Hines	Hines	Illinois
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Hawaii Medical Center - East	Honolulu	Hawaii
United States	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii
United States	Memorial Hermann Hospital - Memorial City	Houston	Texas
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Cleveland Clinic Cancer Center	Independence	Ohio
United States	Foote Memorial Hospital	Jackson	Michigan
United States	West Tennessee Cancer Center at Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Baptist Medical Center South	Jacksonville	Florida
United States	Integrated Community Oncology Network at Southside Cancer Center	Jacksonville	Florida
United States	Integrated Community Oncology Network	Jacksonville Beach	Florida
United States	UPMC Cancer Center at the John P. Murtha Pavilion	Johnstown	Pennsylvania
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Howard Community Hospital	Kokomo	Indiana
United States	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin
United States	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin
United States	Rebecca and John Moores UCSD Cancer Center	La Jolla	California
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	St. Mary Regional Cancer Center	Langhorne	Pennsylvania
United States	Sparrow Regional Cancer Center	Lansing	Michigan
United States	University of New Mexico Cancer Center - South	Las Cruces	New Mexico
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Lawrence Memorial Hospital	Lawrence	Kansas
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Texas Oncology, PA at Lake Vista Cancer Center	Lewisville	Texas
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Lima Memorial Hospital	Lima	Ohio
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center	Lincoln	Nebraska
United States	St. Mary Mercy Hospital	Livonia	Michigan
United States	Logan Regional Hospital	Logan	Utah
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado
United States	Longview Cancer Center	Longview	Texas
United States	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	Norton Suburban Hospital	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Lowell General Hospital	Lowell	Massachusetts
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Immanuel St. Joseph's	Mankato	Minnesota
United States	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota
United States	Minnesota Oncology - Maplewood	Maplewood	Minnesota
United States	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Marlton	New Jersey
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Northwest Ohio Oncology Center	Maumee	Ohio
United States	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	UPMC Cancer Center at UPMC McKeesport	McKeesport	Pennsylvania
United States	Dubs Cancer Center at Rogue Valley Medical Center	Medford	Oregon
United States	Providence Cancer Center at PMCC	Medford	Oregon
United States	Community Memorial Hospital Cancer Care Center	Menomonee Falls	Wisconsin
United States	Lake/University Ireland Cancer Center	Mentor	Ohio
United States	Columbia Saint Mary's Hospital - Ozaukee	Mequon	Wisconsin
United States	Baptist-South Miami Regional Cancer Program	Miami	Florida
United States	Southwest General Health Center	Middleburg Heights	Ohio
United States	Middlesex Hospital Cancer Center	Middletown	Connecticut
United States	Upper Delaware Valley Cancer Center	Milford	Pennsylvania
United States	Columbia-Saint Mary's Water Tower Medical Commons	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee	Milwaukee	Wisconsin
United States	Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota
United States	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	Providence Holy Cross Cancer Center	Mission Hills	California
United States	Memorial Medical Center	Modesto	California
United States	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois
United States	Intercommunity Cancer Center	Monroeville	Pennsylvania
United States	UPMC - Moon	Moon	Pennsylvania
United States	Coleman Radiation Oncology Center at Carter General Hospital	Morehead City	North Carolina
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	D.N. Greenwald Center	Mukwonago	Wisconsin
United States	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah
United States	Alle-Kiski Medical Center	Natrona Heights	Pennsylvania
United States	UPMC Cancer Center - Natrona Heights	Natrona Heights	Pennsylvania
United States	CarolinaEast Cancer Care	New Bern	North Carolina
United States	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus	New Britain	Connecticut
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Jameson Memorial Hospital - North Campus	New Castle	Pennsylvania
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana
United States	St. Luke's - Roosevelt Hospital Center - St.Luke's Division	New York	New York
United States	Stich Radiation Center at NewYork-Presbyterian Hospital/Weill Cornell Medical Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio
United States	Sentara Cancer Institute at Sentara Norfolk General Hospital	Norfolk	Virginia
United States	William W. Backus Hospital	Norwich	Connecticut
United States	Sutter Health - Western Division Cancer Research Group	Novato	California
United States	Alta Bates Summit Medical Center - Summit Campus	Oakland	California
United States	Bay Area Breast Surgeons, Incorporated	Oakland	California
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Larry G Strieff MD Medical Corporation	Oakland	California
United States	Tom K Lee, Incorporated	Oakland	California
United States	Regional Cancer Center at Oconomowoc Memorial Hospital	Oconomowoc	Wisconsin
United States	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Immanuel Medical Center	Omaha	Nebraska
United States	Lakeside Hospital	Omaha	Nebraska
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Nebraska Medical Center	Omaha	Nebraska
United States	St. Joseph Hospital Regional Cancer Center - Orange	Orange	California
United States	Integrated Community Oncology Network - Orange Park	Orange Park	Florida
United States	UHHS Chagrin Highlands Medical Center	Orange Village	Ohio
United States	St. Charles Mercy Hospital	Oregon	Ohio
United States	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida
United States	Florida Cancer Center - Palatka	Palatka	Florida
United States	Cancer Center of Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Feather River Hospital Cancer Center	Paradise	California
United States	Parma Community General Hospital	Parma	Ohio
United States	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Capital Health Regional Cancer Center	Pennington	New Jersey
United States	Arizona Center for Cancer Care - Peoria	Peoria	Arizona
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Arizona Oncology Services Foundation	Phoenix	Arizona
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	UPMC - Shadyside	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center - Upper St. Clair	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC Passavant	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at UPMC St. Margaret	Pittsburgh	Pennsylvania
United States	St. Joseph Mercy Oakland	Pontiac	Michigan
United States	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan
United States	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon
United States	Naval Medical Center - Portsmouth	Portsmouth	Virginia
United States	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio
United States	Dyson Center for Cancer Care at Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Hudson Valley Oncology Associates	Poughkeepsie	New York
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin
United States	Rex Cancer Center at Rex Hospital	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center	Reading	Pennsylvania
United States	St. Joseph Medical Center	Reading	Pennsylvania
United States	Annie Penn Cancer Center	Reidsville	North Carolina
United States	Veterans Affairs Medical Center - Richmond	Richmond	Virginia
United States	Valley Hospital - Ridgewood	Ridgewood	New Jersey
United States	Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota
United States	Highland Hospital of Rochester	Rochester	New York
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Lipson Cancer and Blood Center at Rochester General Hospital	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	University Radiation Oncology at Parkridge Hospital	Rochester	New York
United States	Memorial Sloan-Kettering Cancer Center - Rockville Centre	Rockville Centre	New York
United States	Radiation Oncology Center - Roseville	Roseville	California
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Mercy General Hospital	Sacramento	California
United States	Radiological Associates of Sacramento Medical Group, Incorporated	Sacramento	California
United States	University of California Davis Cancer Center	Sacramento	California
United States	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan
United States	Flagler Cancer Center	Saint Augustine	Florida
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Saint Helena Hospital	Saint Helena	California
United States	Norris Cotton Cancer Center - North	Saint Johnsbury	Vermont
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Barnes-Jewish West County Hospital	Saint Louis	Missouri
United States	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Park Nicollet Cancer Center	Saint Louis Park	Minnesota
United States	Regions Hospital Cancer Care Center	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters	Saint Peters	Missouri
United States	Cancer Care Center, Incorporated	Salem	Ohio
United States	Salem Hospital Regional Cancer Care Services	Salem	Oregon
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Cancer Care Centers of South Texas - Northeast	San Antonio	Texas
United States	California Pacific Medical Center - California Campus	San Francisco	California
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	North Coast Cancer Care, Incorporated	Sandusky	Ohio
United States	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota
United States	Texas Oncology, PA at Texas Cancer Center - Sherman	Sherman	Texas
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center	Sleepy Hollow	New York
United States	Somerset Medical Center	Somerville	New Jersey
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Frederick R. and Betty M. Smith Cancer Treatment Center	Sparta	New Jersey
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Cancer Institute at St. John's Hospital	Springfield	Illinois
United States	Community Hospital of Springfield and Clark County	Springfield	Ohio
United States	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois
United States	Tony Teramana Cancer Center	Steubenville	Ohio
United States	Cleveland Clinic Foundation - Strongsville	Strongsville	Ohio
United States	Door County Cancer Center at Door County Memorial Hospital	Sturgeon Bay	Wisconsin
United States	Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land	Sugar Land	Texas
United States	Aurora Medical Center	Summit	Wisconsin
United States	South Atlantic Radiation Oncology, LLC	Supply	North Carolina
United States	Flower Hospital Cancer Center	Sylvania	Ohio
United States	CCOP - Northwest	Tacoma	Washington
United States	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	Veterans Affairs Medical Center - Tampa	Tampa	Florida
United States	North Suburban Medical Center	Thornton	Colorado
United States	Mercy Hospital of Tiffin	Tiffin	Ohio
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Medical University of Ohio Cancer Center	Toledo	Ohio
United States	St. Anne Mercy Hospital	Toledo	Ohio
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Arizona Oncology - Tucson	Tucson	Arizona
United States	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma
United States	Tyler Cancer Center	Tyler	Texas
United States	Solano Radiation Oncology Center	Vacaville	California
United States	Sutter Solano Medical Center	Vallejo	California
United States	Legacy Salmon Creek Medical Center	Vancouver	Washington
United States	Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare	Vineland	New Jersey
United States	Coastal Cancer Center at Sentara Virginia Beach General Hospital	Virginia Beach	Virginia
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Fox Chase Virtua Health Cancer Program at Virtua West Jersey	Voorhees	New Jersey
United States	Ridgeview Medical Center	Waconia	Minnesota
United States	Pacific Cancer Institute - Maui	Wailuku	Hawaii
United States	St. John Macomb Hospital	Warren	Michigan
United States	Washington Cancer Institute at Washington Hospital Center	Washington	District of Columbia
United States	Washington Hospital Cancer Center	Washington	Pennsylvania
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	University of Wisconcin Cancer Center at Aspirus Wausau Hospital	Wausau	Wisconsin
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	West Allis Memorial Hospital	West Allis	Wisconsin
United States	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio
United States	UHHS Westlake Medical Center	Westlake	Ohio
United States	Exempla Lutheran Medical Center	Wheat Ridge	Colorado
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Wesley Medical Center	Wichita	Kansas
United States	Texas Oncology, PA - Wichita Falls	Wichita Falls	Texas
United States	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania
United States	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota
United States	Coastal Carolina Radiation Oncology Center	Wilmington	North Carolina
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas
United States	Riverview UW Cancer Center at Riverview Hospital	Wisconsin Rapids	Wisconsin
United States	Minnesota Oncology - Woodbury	Woodbury	Minnesota
United States	Cancer Treatment Center	Wooster	Ohio
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	CCOP - Main Line Health	Wynnewood	Pennsylvania
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania
United States	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington
United States	York Cancer Center at Apple Hill Medical Center	York	Pennsylvania
United States	Genesis - Good Samaritan Hospital	Zanesville	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	Cancer and Leukemia Group B, National Cancer Institute (NCI), NRG Oncology

Countries where clinical trial is conducted

United States,  Canada,  China,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Free From Progression (FFP) at 5 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	Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)	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.
Secondary	Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)	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.
Secondary	Percentage of Participants With Local Failure	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.
Secondary	Percentage of Participants With Distant Metastasis	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.
Secondary	Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)	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.
Secondary	Percentage of Participants Alive (Overall Mortality)	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.
Secondary	Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events = 90 Days of the Completion of Radiotherapy (RT)	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).
Secondary	Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)	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.
Secondary	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)		From the 6th week of radiation therapy to 5 years post radiation therapy.
Secondary	Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25)		From the 6th week of radiation therapy to 5 years post radiation therapy.
Secondary	Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY)		From the 6th week of radiation therapy to 5 years post radiation therapy.
Secondary	Evaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D)		From the 6th week of radiation therapy to 5 years post radiation therapy.
Secondary	Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints		Date of randomization to timepoint of the respective primary or secondary endpoint.
Secondary	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		From the 6th week of radiation therapy to 5 years post radiation therapy.