Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005044
• Other study ID #: RTOG-9910
• Secondary ID: CDR0000067635
• Status: Completed
• Phase: Phase 3
• Start date: February 2000
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Description:

OBJECTIVES:

• Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS and RT, as related to disease-specific survival, in patients with intermediate-risk adenocarcinoma of the prostate.

• Compare these regimens, in terms of overall survival, disease-free survival, time to local tumor progression or distant failure, time to first biochemical failure, hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo radiotherapy 5 days a week for 8 weeks.

• Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1579
• Est. completion date: May 20, 2022
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria

1. Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date.

2. Zubrod Performance Status 0-1 (Appendix II).

3. Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization.

4. Patients at intermediate risk for disease relapse as determined by any of the following combinations of factors (NOTE: tumor found in one or both lobes on biopsy, but not palpable, will not alter T stage):

• Clinical stage T1b-4, Gleason score 2-6, and prostate-specific antigen >10 but = 100.

• Clinical stage T1b-4, Gleason score 7, and prostate-specific antigen < 20.

• Clinical stage T1b-1c, Gleason score 8-10, and prostate-specific antigen <20.

5. Clinically negative (N0) lymph nodes (LN) as established by imaging (pelvic ± abdominal CT, MRI or LAG), or negative LN by nodal sampling or dissection (laparoscopy or laparotomy). Patients with radiologic (e.g., CT, MRI or LAG) or radioimmunoscintigraphy (i.e., ProstaScint™) findings suggestive of regional nodal involvement are eligible if cytologic (e.g., needle aspiration) or histologic (e.g., surgical sampling) evaluation shows no evidence of a neoplastic process (i.e., prostatic or non-prostatic malignancy). Patients with equivocal radiologic findings (maximum nodal size = 1.5 cm) are eligible.

6. No distant (M0) metastases. Patients with radionuclide imaging (e.g., bone scintigraphy, ProstaScint™) findings suggestive, but not diagnostic of metastatic disease are eligible if radiologic (e.g., standard or tomographic radiography, or CT/MRI) imaging does not confirm metastatic disease.

7. Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug Administration approved assay method, e.g. Abbott, Hybritech, etc.

8. Treatment must begin within 6 weeks after randomization.

9. Alanine aminotransferase (ALT) must be within 2 x upper normal limit.

10. Patients must sign a study-specific informed consent form (Appendix I) prior to randomization.

Exclusion Criteria

1. Patients at high risk for disease relapse as determined by either:

• Prostate-specific antigen = 20 and Gleason score = 7 (any T stage).

• Clinical stage =T2 and Gleason score = 8 (any prostate-specific antigen).

2. Patients at low risk for disease relapse as determined by:

• Clinical stage =T2, Gleason score = 6, and prostate-specific antigen = 10.

3. Clinical stage Tx, T0, or T1a.

4. Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1).

5. Pretherapy serum prostate-specific antigen level > 100.

6. Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of <10 years.

7. Any of the following prior therapies:

• Pelvic external beam radiation therapy.

• Radionuclide prostate brachytherapy.

• Prostatectomy or prostatic cryosurgery.

• Prior bilateral orchiectomy.

• Prior androgen suppression therapy; however, patients begun on LHRH agonist therapy remain eligible if (1) LHRH agonists were started no more than 30 days before randomization, and (2) Casodex or Eulexin was (or will be) started no more than 14 days before or after the date that the LHRH agonist injection was given. Any finasteride therapy administered for prostatic hypertrophy must be discontinued.

• Chemotherapy for prostatic carcinoma.

8. Previous or concomitant invasive cancer, other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), unless continually disease free for at least 5 years.

9. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up.

10. The patient's participation in another medical research study that involves prostate cancer treatment.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Casodex
Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.
• Eulexin
Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.
• LHRH agonist
LHRH agonist of choice. The manufacturer's instructions should be followed.

Radiation:
• radiation therapy
[Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Doctor Leon Richard Oncology Centre	Moncton	New Brunswick
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre - Sudbury	Sudbury	Ontario
Canada	Northwestern Ontario Regional Cancer Care	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Akron City Hospital	Akron	Ohio
United States	Akron General Medical Center	Akron	Ohio
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Radiation Oncology Associates of Albuquerque	Albuquerque	New Mexico
United States	John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Harrington Cancer Center	Amarillo	Texas
United States	St. John's Medical Center	Anderson	Indiana
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Anne Arundel Oncology Center	Annapolis	Maryland
United States	Arlington Cancer Center	Arlington	Texas
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Greater Baltimore Medical Center and Cancer Center	Baltimore	Maryland
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	St. Agnes Cancer Center	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Green Mountain Oncology Group	Bennington	Vermont
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Bloomington Hospital	Bloomington	Indiana
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Vermont Cancer Center at University of Vermont	Burlington	Vermont
United States	Cooper Cancer Institute	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Cancer Center at Christ Hospital	Cincinnati	Ohio
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Finger Lakes Radiation Oncology Center	Clifton Springs	New York
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Medical Center/John B. Amos Community Cancer Center	Columbus	Georgia
United States	Batte Cancer Center at Northeast Medical Center	Concord	North Carolina
United States	Mount Diablo Medical Center	Concord	California
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Wendt Regional Cancer Center of Finley Hospital	Dubuque	Iowa
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Pocono Cancer Center	East Stroudsburg	Pennsylvania
United States	St. Elizabeth Medical Center	Edgewood	Kentucky
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Trinitas Hospital - Jersey Street Campus	Elizabeth	New Jersey
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Regional Cancer Center	Flint	Michigan
United States	21st Century Oncology - Fort Myers	Fort Myers	Florida
United States	California Cancer Center	Fresno	California
United States	Saint Agnes Cancer Center	Fresno	California
United States	Shands Cancer Center at the University of Florida Health Science Center	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Sutter Health Western Division Cancer Research Group	Greenbrae	California
United States	CCOP - Greenville	Greenville	South Carolina
United States	Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina	Greenville	North Carolina
United States	RMH Regional Cancer Center	Harrisonburg	Virginia
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Institute	Huntsville	Alabama
United States	Huntsville Hospital	Huntsville	Alabama
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Community Regional Cancer Care	Indianapolis	Indiana
United States	Methodist Cancer Center at Methodist Hospital	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	West Tennessee Cancer Center at Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Florida Radiation Oncology Group	Jacksonville	Florida
United States	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth Medical School	Lebanon	New Hampshire
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Louisville Radiation Oncology Center at Caritas Regional Cancer Center	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Southern Wisconsin Radiotherapy Center	Madison	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Merle M. Mahr Cancer Center	Madisonville	Kentucky
United States	Elliot Regional Cancer Center	Manchester	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Marquette General Hospital	Marquette	Michigan
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Community Memorial Hospital	Menomonee Falls	Wisconsin
United States	Baptist Hospital of Miami	Miami	Florida
United States	University of Miami Sylvester Cancer Center	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MidMichigan Medical Center - Midland	Midland	Michigan
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Columbia Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Fairview University Medical Center - University Campus	Minneapolis	Minnesota
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	Montgomery Cancer Center	Montgomery	Alabama
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Ball Memorial Hospital Cancer Center	Muncie	Indiana
United States	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center	Nashville	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Hospital of St. Raphael	New Haven	Connecticut
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Beth Israel Medical Center - Philipps Ambulatory Care Center	New York	New York
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	Frank C. Love Cancer Institute at St. Anthony Hospital	Oklahoma City	Oklahoma
United States	Oklahoma University Medical Center at University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha	Omaha	Nebraska
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	MD Anderson Cancer Center Orlando	Orlando	Florida
United States	Bay Medical Center	Panama City	Florida
United States	Gulf Coast Cancer Treatment Center	Panama City	Florida
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Parma Community General Hospital	Parma	Ohio
United States	Bayshore Medical Center	Pasadena	Texas
United States	Huntington Cancer Center at Huntington Hospital	Pasadena	California
United States	NSMC Cancer Center	Peabody	Massachusetts
United States	CCOP - Scott and White Hospital	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Veterans Affairs Medical Center - Philadelphia	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Champlain Valley Physicians Hospital Medical Center	Plattsburgh	New York
United States	Atlantic City Medical Center	Pomona	New Jersey
United States	Robert and Beverly Lewis Family Cancer Care Center	Pomona	California
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Maine Medical Center	Portland	Maine
United States	Naval Medical Center, Portsmouth	Portsmouth	Virginia
United States	Medical Center of Princeton	Princeton	New Jersey
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	All Saints Cancer Center at All Saints Healthcare	Racine	Wisconsin
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Bon Secours - St. Mary's Hospital	Richmond	Virginia
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Regional Radiation Oncology Center at Rome	Rome	Georgia
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	William Beaumont Hospital - Royal Oak	Royal Oak	Michigan
United States	Radiation Oncology Center - Sacramento	Sacramento	California
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Mallinckrodt Institute of Radiology	Saint Louis	Missouri
United States	St. Louis University Hospital Cancer Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Naval Medical Center - San Diego	San Diego	California
United States	Radiation Medical Group, Incorporated	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	O'Connor Hospital	San Jose	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Sarasota Radiation and Medical Oncology Center	Sarasota	Florida
United States	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania
United States	Cancer Institute at Virginia Mason Medical Center	Seattle	Washington
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Somerset Medical Center	Somerville	New Jersey
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Deaconess Medical Center	Spokane	Washington
United States	Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Community Medical Center	Toms River	New Jersey
United States	Torrance Memorial Medical Center	Torrance	California
United States	David Grant Medical Center	Travis Air Force Base	California
United States	Fox Chase Cancer Center at St. Francis Medical Center	Trenton	New Jersey
United States	William Beaumont Hospital - Troy	Troy	Michigan
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	St. John Health System	Tulsa	Oklahoma
United States	DCH Cancer Treatment Center	Tuscaloosa	Alabama
United States	Associated Radiologists, P.A.	Warren	New Jersey
United States	Sibley Memorial Hospital	Washington	District of Columbia
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	Schiffler Cancer Center	Wheeling	West Virginia
United States	Wilkes-Barre General Hospital	Wilkes-Barre	Pennsylvania
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania
United States	Yakima Valley Memorial Hospital	Yakima	Washington
United States	Riverhill Radiation Oncology	Yonkers	New York
United States	Wellspan Health - York Cancer Center	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Pisansky TM, Hunt D, Gomella LG, Amin MB, Balogh AG, Chinn DM, Seider MJ, Duclos M, Rosenthal SA, Bauman GS, Gore EM, Rotman MZ, Lukka HR, Shipley WU, Dignam JJ, Sandler HM. Duration of androgen suppression before radiotherapy for localized prostate cance — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-specific Survival (DSS) (10-year Rates Reported)	Disease-specific survival time is measured from date of randomization to death due to prostate cancer based on study chair review, with prostate-cancer death defined as (1) primary cause of death certified as due to prostate cancer, (2) complication of therapy, irrespective of disease status, (3) disease progression in the absence of any anti-tumor therapy, or (4) a 1.0 ng/ml-exceeding-rise in serum prostate-specific antigen (PSA) level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy. Death due to other causes is considered a competing risk. All others are censored. DSS is estimated using the cumulative incidence method. Ten-year rate is reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Secondary	Overall Survival (OS) (10-year Rates Reported)	Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Secondary	Disease-free Survival (DFS) (10-year Rates Reported)	Disease-free survival time is defined as time from randomization to the date of disease progression or death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Ten-year rate is reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Secondary	Clinical Patterns of Tumor Recurrence: Time to Locoregional Progression (LRP) and Time to Distant Metastasis (DM) (10 Year Rates Reported)	Time to distant metastasis measured from date of randomization to date of documented distant metastasis; competing risks are BF, LRP, and death without DM; all others are censored. Time to locoregional progression measured from date of randomization to date of documented local or regional progression; competing risks are BF [protocol definition- first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy], DM, and death without LRP; all others are censored. LRP and DM are estimated using the cumulative incidence method. Ten -year rates are reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Secondary	Time to First Biochemical Failure (BF) (10-year Rates Reported)	Protocol definition: Time to BF measured from date of randomization to first of (1) the midway date between the last non-rising PSA and the first rising PSA of three consecutive rises or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored.; Phoenix definition: Time to BF measured from date of randomization to first of (1) the date of documented rise of 2 ng/ml above the post-treatment(RT end date) nadir or (2) the date of the initiation of salvage hormone therapy; competing risks are LRP, DM, and death without BF; all others are censored. For both definitions BF is estimated using the cumulative incidence method. Ten year rates reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Secondary	Time to Second Biochemical Failure (SBF) (10-year Rates Reported)	Time to SBF measured from date of randomization to the date of PSA increase of =1.0 ng/mL (from the nadir PSA after completion of protocol-specified therapy) after salvage androgen suppression was started; competing risks LRP, DM, and death without SBF; all others are censored. SBF is estimated using the cumulative incidence method. Ten-year rates are reported.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)
Secondary	Treatment-induced Morbidity (Highest Grade Toxicity Reported Per Patient)	Acute drug therapy and radiation (<= 90 days from start of RT) toxicity was graded using the Common Toxicity Criteria (CTC) v.2.0 criteria; late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring schema. Grade refers to the severity of the toxicity. The CTC v2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild toxicity, Grade 2 Moderate toxicity, Grade 3 Severe toxicity, Grade 4 Life-threatening or disabling toxicity, Grade 5 Death related to toxicity. The highest grade acute and late toxicity was determined for each patient.	From randomization to 10 years. (Patients are followed until death or study termination, whichever occurs first.)