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Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Casodex

Eulexin

LHRH agonist

radiation therapy

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria Adenocarcinoma of prostatic origin histologically-confirmed within 180 days of the randomization date. Zubrod Performance Status 0-1 (Appendix II). Prostatic biopsy tumor grading by the Gleason Score classification (Appendix VI) is mandatory prior to randomization. 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. 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. 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. Pretherapy serum (total) prostate-specific antigen value performed with a Federal Drug Administration approved assay method, e.g. Abbott, Hybritech, etc. Treatment must begin within 6 weeks after randomization. Alanine aminotransferase (ALT) must be within 2 x upper normal limit. Patients must sign a study-specific informed consent form (Appendix I) prior to randomization. Exclusion Criteria 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). Patients at low risk for disease relapse as determined by: • Clinical stage ≤T2, Gleason score ≤ 6, and prostate-specific antigen ≤ 10. Clinical stage Tx, T0, or T1a. Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1). Pretherapy serum prostate-specific antigen level > 100. Co-morbid medical illness which in the opinion of the investigator is expected to result in a life expectancy of <10 years. 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. 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. Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up. The patient's participation in another medical research study that involves prostate cancer treatment.

Sites / Locations

University of Alabama at Birmingham Comprehensive Cancer Center
Comprehensive Cancer Institute
Huntsville Hospital
MBCCOP - Gulf Coast
Montgomery Cancer Center
DCH Cancer Treatment Center
Foundation for Cancer Research and Education
Providence Saint Joseph Medical Center - Burbank
Mount Diablo Medical Center
City of Hope Comprehensive Cancer Center
California Cancer Center
Saint Agnes Cancer Center
Sutter Health Western Division Cancer Research Group
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Veterans Affairs Medical Center - Long Beach
USC/Norris Comprehensive Cancer Center and Hospital
Jonsson Comprehensive Cancer Center, UCLA
CCOP - Bay Area Tumor Institute
Huntington Cancer Center at Huntington Hospital
Robert and Beverly Lewis Family Cancer Care Center
Radiation Oncology Center - Sacramento
Radiation Medical Group, Incorporated
Naval Medical Center - San Diego
UCSF Comprehensive Cancer Center
O'Connor Hospital
CCOP - Santa Rosa Memorial Hospital
Torrance Memorial Medical Center
David Grant Medical Center
Memorial Hospital Cancer Center
University of Colorado Cancer Center at University of Colorado Health Sciences Center
CCOP - Colorado Cancer Research Program, Incorporated
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Hospital of St. Raphael
Yale Comprehensive Cancer Center
CCOP - Christiana Care Health Services
Sibley Memorial Hospital
21st Century Oncology - Fort Myers
Shands Cancer Center at the University of Florida Health Science Center
Florida Radiation Oncology Group
Holmes Regional Medical Center
CCOP - Mount Sinai Medical Center
University of Miami Sylvester Cancer Center
Baptist Hospital of Miami
MD Anderson Cancer Center Orlando
Bay Medical Center
Gulf Coast Cancer Treatment Center
Sarasota Radiation and Medical Oncology Center
Tallahassee Memorial Hospital
H. Lee Moffitt Cancer Center and Research Institute
Winship Cancer Institute of Emory University
CCOP - Atlanta Regional
Medical Center/John B. Amos Community Cancer Center
Regional Radiation Oncology Center at Rome
MBCCOP - Hawaii
Northwest Community Hospital
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
CCOP - Central Illinois
Ingalls Memorial Hospital
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Lutheran General Cancer Care Center
CCOP - Scott and White Hospital
Methodist Medical Center of Illinois
St. John's Medical Center
Bloomington Hospital
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Methodist Cancer Center at Methodist Hospital
Community Regional Cancer Care
Ball Memorial Hospital Cancer Center
CCOP - Northern Indiana CR Consortium
Wendt Regional Cancer Center of Finley Hospital
St. Elizabeth Medical Center
Central Baptist Hospital
Markey Cancer Center at University of Kentucky Chandler Medical Center
James Graham Brown Cancer Center at University of Louisville
Louisville Radiation Oncology Center at Caritas Regional Cancer Center
Merle M. Mahr Cancer Center
Mary Bird Perkins Cancer Center
Tulane University School of Medicine
MBCCOP - LSU Health Sciences Center
CCOP - Ochsner
Maine Medical Center
Anne Arundel Oncology Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Greater Baltimore Medical Center and Cancer Center
Harbor Hospital Center
Sinai Hospital of Baltimore
St. Agnes Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Peninsula Regional Medical Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Cancer Research Center at Boston Medical Center
Cape Cod Hospital
Veterans Affairs Medical Center - Boston (Jamaica Plain)
NSMC Cancer Center
CCOP - Michigan Cancer Research Consortium
University of Michigan Comprehensive Cancer Center
Barbara Ann Karmanos Cancer Institute
Josephine Ford Cancer Center at Henry Ford Hospital
Hurley Medical Center
McLaren Regional Cancer Center
CCOP - Kalamazoo
Marquette General Hospital
MidMichigan Medical Center - Midland
CCOP - Beaumont
William Beaumont Hospital - Royal Oak
William Beaumont Hospital - Troy
Fairview University Medical Center - University Campus
Mayo Clinic Cancer Center
CCOP - Metro-Minnesota
Ellis Fischel Cancer Center at University of Missouri - Columbia
CCOP - Kansas City
St. Louis University Hospital Cancer Center
Mallinckrodt Institute of Radiology
Cancer Research for the Ozarks
CCOP - Cancer Research for the Ozarks
CCOP - Montana Cancer Consortium
CCOP - Missouri Valley Cancer Consortium
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
CCOP - Southern Nevada Cancer Research Foundation
Comprehensive Cancer Centers of Nevada
Norris Cotton Cancer Center at Dartmouth Medical School
Elliot Regional Cancer Center
Cooper Cancer Institute
Veterans Affairs Medical Center - East Orange
John F. Kennedy Medical Center
Trinitas Hospital - Jersey Street Campus
Monmouth Medical Center
South Jersey Regional Cancer Center
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Cancer Institute of New Jersey
Newark Beth Israel Medical Center
Atlantic City Medical Center
Medical Center of Princeton
Valley Hospital
Somerset Medical Center
Community Medical Center
Fox Chase Cancer Center at St. Francis Medical Center
Associated Radiologists, P.A.
Radiation Oncology Associates of Albuquerque
Cancer Center of Albany Medical Center
State University of New York Health Science Center at Brooklyn
New York Methodist Hospital
Roswell Park Cancer Institute
Finger Lakes Radiation Oncology Center
CCOP - North Shore University Hospital
Beth Israel Medical Center - Philipps Ambulatory Care Center
Herbert Irving Comprehensive Cancer Center at Columbia University
Champlain Valley Physicians Hospital Medical Center
James P. Wilmot Cancer Center at University of Rochester Medical Center
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Riverhill Radiation Oncology
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Batte Cancer Center at Northeast Medical Center
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
CCOP - Southeast Cancer Control Consortium
Comprehensive Cancer Center at Wake Forest University
Trinity Cancer Care Center
Akron General Medical Center
Akron City Hospital
Cancer Center at Christ Hospital
Charles M. Barrett Cancer Center at University Hospital
Ireland Cancer Center
University Hospitals of Cleveland
Cleveland Clinic Taussig Cancer Center
CCOP - Columbus
Arthur G. James Cancer Hospital - Ohio State University
CCOP - Dayton
Parma Community General Hospital
CCOP - Toledo Community Hospital
Frank C. Love Cancer Institute at St. Anthony Hospital
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
St. John Health System
CCOP - Oklahoma
CCOP - Columbia River Oncology Program
Abington Memorial Hospital
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
St. Luke's Hospital Cancer Center
Geisinger Medical Center
Mercy Fitzgerald Hospital
Delaware County Memorial Hospital
Pocono Cancer Center
Penn State Cancer Institute at Milton S. Hershey Medical Center
Abramson Cancer Center at University of Pennsylvania Medical Center
Veterans Affairs Medical Center - Philadelphia
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase Cancer Center
Albert Einstein Cancer Center
Allegheny General Hospital
Mercy Hospital of Pittsburgh
Western Pennsylvania Hospital
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Reading Hospital and Medical Center
Mercy Hospital Cancer Center - Scranton
Wilkes-Barre General Hospital
CCOP - MainLine Health
Wellspan Health - York Cancer Center
Roger Williams Medical Center
CCOP - Greenville
CCOP - Upstate Carolina
Rapid City Regional Hospital
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Harrington Cancer Center
Arlington Cancer Center
University of Texas Medical Branch
University of Texas - MD Anderson Cancer Center
Wilford Hall Medical Center
Joe Arrington Cancer Research and Treatment Center
Bayshore Medical Center
University of Texas Health Science Center at San Antonio
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center
University of Utah Health Sciences Center
LDS Hospital
Green Mountain Oncology Group
Vermont Cancer Center at University of Vermont
Cancer Center at the University of Virginia
RMH Regional Cancer Center
Naval Medical Center, Portsmouth
Bon Secours - St. Mary's Hospital
Massey Cancer Center at Virginia Commonwealth University
Cancer Institute at Virginia Mason Medical Center
University Cancer Center at University of Washington Medical Center
Deaconess Medical Center
Yakima Valley Memorial Hospital
Schiffler Cancer Center
CCOP - St. Vincent Hospital Cancer Center, Green Bay
St. Vincent Hospital
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
Southern Wisconsin Radiotherapy Center
University of Wisconsin Comprehensive Cancer Center
CCOP - Marshfield Clinic Research Foundation
Marshfield Clinic
Community Memorial Hospital
Columbia Hospital
St. Luke's Medical Center
Medical College of Wisconsin Cancer Center
Veterans Affairs Medical Center - Milwaukee (Zablocki)
All Saints Cancer Center at All Saints Healthcare
Waukesha Memorial Hospital Regional Cancer Center
Tom Baker Cancer Center - Calgary
Cross Cancer Institute
Doctor Leon Richard Oncology Centre
Saint John Regional Hospital
Newfoundland Cancer Treatment and Research Foundation
Nova Scotia Cancer Centre
Margaret and Charles Juravinski Cancer Centre
Kingston Regional Cancer Centre
Cancer Care Ontario-London Regional Cancer Centre
Ottawa Regional Cancer Centre
Northeastern Ontario Regional Cancer Centre - Sudbury
Northwestern Ontario Regional Cancer Care
Toronto Sunnybrook Regional Cancer Centre
Princess Margaret Hospital
CHUS-Hopital Fleurimont
Centre Hospitalier de l'Universite de Montreal
McGill University
Centre Hospitalier Universitaire de Quebec
Allan Blair Cancer Centre
Saskatoon Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

TAS x 8 weeks

TAS x 28 weeks

Arm Description

Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).

TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00005044

First Posted

April 6, 2000

Last Updated

May 23, 2022

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00005044

Brief Title

Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

February 2000 (Actual)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1579 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAS x 8 weeks

Arm Type

Experimental

Arm Description

Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).

Arm Title

TAS x 28 weeks

Arm Type

Experimental

Arm Description

TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).

Intervention Type

Drug

Intervention Name(s)

Casodex

Other Intervention Name(s)

bicalutamide

Intervention Description

Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.

Intervention Type

Drug

Intervention Name(s)

Eulexin

Other Intervention Name(s)

flutamide

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

LHRH agonist

Other Intervention Name(s)

Zoladex, Lupron, Eligard, Viadur, luteinizing hormone-releasing hormone (LHRH)-agonist

Intervention Description

LHRH agonist of choice. The manufacturer's instructions should be followed.

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

[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]

Primary Outcome Measure Information:

Title

Disease-specific Survival (DSS) (10-year Rates Reported)

Description

Time Frame