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Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dexamethasone

Prednisone

docetaxel

Oral antiandrogen

Radiation therapy

LHRH agonist

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer at high-risk for recurrence within the past 180 days as determined by 1 of the following combinations (risk groups): Gleason score ≥ 9, prostate-specific antigen (PSA) ≤ 150 ng/mL, and any T stage Gleason score 8, PSA < 20 ng/mL, and stage ≥ T2 Gleason score 8, PSA 20-150 ng/mL, and any T stage Gleason score 7, PSA 20-150 ng/mL, and any T stage Clinically negative lymph nodes by imaging (pelvic CT scan or pelvic MRI), nodal sampling, or dissection within 90 days prior to study entry Equivocal or questionable lymph nodes ≤ 1.5 cm by imaging allowed Positive lymph nodes by capromab pendetide (ProstaScint^®) scan with a corresponding lymph node ≤ 1.5 cm by CT scan or MRI allowed PSA ≤ 150 ng/mL Cannot have been obtained during any of the following time points: 10-day period after prostate biopsy After initiation of hormonal therapy Within 30 days after discontinuation of finasteride Within 90 days after discontinuation of dutasteride No distant metastases by physical exam and bone scan Equivocal bone scan findings allowed if plain films are negative PATIENT CHARACTERISTICS: Zubrod performance status 0-1 Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,800/mm^3 Hemoglobin ≥ 8 g/dL (transfusion or other intervention allowed) Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 1.5 times ULN Fertile patients must use effective contraception during and for at least 3 months after completion of study treatment No prior invasive malignancy, except nonmelanomatous skin cancer or other malignancy, unless disease-free for ≥ 3 years (e.g., carcinoma in situ of the oral cavity or bladder are allowed) No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months No transmural myocardial infarction within the past 6 months No acute bacterial or fungal infection requiring intravenous antibiotics No AIDS No prior allergic reaction to any study drugs or other drugs formulated with polysorbate 80 No existing peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: At least 60 days since prior 5-alpha reductase inhibitor (e.g., finasteride) for prostatic hypertrophy At least 90 days since prior testosterone Prior pharmacologic androgen ablation for prostate cancer allowed provided androgen ablation was initiated no more than 50 days prior to study entry No prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy No prior systemic chemotherapy for prostate cancer Prior chemotherapy for a different cancer is allowed No prior radiotherapy, including brachytherapy, to the region of prostate cancer that would result in overlap of radiotherapy fields Intensity modulated radiotherapy allowed

Sites / Locations

UAB Comprehensive Cancer Center
Providence Cancer Center
Arizona Oncology Services Foundation
Arizona Oncology - Tucson
Auburn Radiation Oncology
Providence Saint Joseph Medical Center - Burbank
Radiation Oncology Centers - Cameron Park
Mercy Cancer Center at Mercy San Juan Medical Center
Enloe Cancer Center at Enloe Medical Center
Cancer Care Center at John Muir Health - Concord Campus
Washington Township Hospital
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
Rebecca and John Moores UCSD Cancer Center
Memorial Medical Center
CCOP - Bay Area Tumor Institute
Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
Radiation Oncology Center - Roseville
Radiological Associates of Sacramento Medical Group, Incorporated
University of California Davis Cancer Center
Mercy General Hospital
California Pacific Medical Center - California Campus
Torrance Memorial Medical Center
Solano Radiation Oncology Center
John Muir/Mt. Diablo Comprehensive Cancer Center
Rocky Mountain Cancer Centers - Aurora
University of Colorado Cancer Center at UC Health Sciences Center
Swedish Medical Center
Poudre Valley Radiation Oncology
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
North Colorado Medical Center
McKee Medical Center
Exempla Lutheran Medical Center
St. Vincent's Medical Center
Bridgeport Hospital
Hospital of Saint Raphael
Yale Cancer Center
Eastern Connecticut Hematology and Oncology Associates
William W. Backus Hospital
CCOP - Christiana Care Health Services
University of Florida Shands Cancer Center
Bay Medical
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Winship Cancer Institute of Emory University
John B. Amos Cancer Center
Northeast Georgia Medical Center
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Cancer Research Center of Hawaii
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Northwest Community Hospital
Decatur Memorial Hospital Cancer Care Institute
Elmhurst Memorial Hospital
Advocate Lutheran General Cancer Care Center
Center for Cancer Care at OSF Saint Anthony Medical Center
Cancer Institute at St. John's Hospital
Regional Cancer Center at Memorial Medical Center
Saint John's Cancer Center at Saint John's Medical Center
Radiation Oncology Associates Southwest
Parkview Regional Cancer Center at Parkview Health
Veterans Affairs Medical Center - Indianapolis
Central Indiana Cancer Centers - East
McFarland Clinic, PC
Holden Comprehensive Cancer Center at University of Iowa
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Cancer Centers - Southwest
Norton Suburban Hospital
Tulane Cancer Center Office of Clinical Research
CCOP - Ochsner
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
DeCesaris Cancer Institute at Anne Arundel Medical Center
St. Agnes Hospital Cancer Center
Suburban Hospital
Massachusetts General Hospital
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Shields Radiation Oncology Center - Mansfield
NSMC Cancer Center - Peabody
South Suburban Oncology Center
Hickman Cancer Center at Bixby Medical Center
University of Michigan Comprehensive Cancer Center
Barbara Ann Karmanos Cancer Institute
Josephine Ford Cancer Center at Henry Ford Hospital
West Michigan Cancer Center
Breslin Cancer Center at Ingham Regional Medical Center
William Beaumont Hospital - Royal Oak Campus
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
St. Luke's Hospital Cancer Care Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Minnesota Oncology Hematology, PA - Maplewood
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
CCOP - Metro-Minnesota
United Hospital
Ridgeview Medical Center
Regional Cancer Center at Singing River Hospital
Cancer Institute of Cape Girardeau, LLC
St. John's Regional Medical Center
Kansas City Cancer Centers - South
Kansas City Cancer Centers - North
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
David C. Pratt Cancer Center at St. John's Mercy
St. John's Regional Health Center
Hulston Cancer Center at Cox Medical Center South
CCOP - Montana Cancer Consortium
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
CCOP - Missouri Valley Cancer Consortium
Methodist Estabrook Cancer Center
Immanuel Medical Center
Alegant Health Cancer Center at Bergan Mercy Medical Center
Creighton University Medical Center
CCOP - Nevada Cancer Research Foundation
Nevada Cancer Institute
Dartmouth - Hitchcock Concord
Seacoast Cancer Center at Wentworth - Douglass Hospital
Center for Cancer Care at Exeter Hospital
Kingsbury Center for Cancer Care at Cheshire Medical Center
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Elliot Regional Cancer Center at Elliot Hospital
Cancer Institute of New Jersey at Cooper University Hospital - Camden
CentraState Medical Center
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Saint Peter's University Hospital
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Cancer Institute of New Jersey at Cooper - Voorhees
Lovelace Medical Center - Downtown
New Mexico Cancer Center
Radiation Oncology Associates, PA
University of New Mexico Cancer Center
Cancer Institute of New Mexico
New York Oncology Hematology, PC at Albany Regional Cancer Care
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
James P. Wilmot Cancer Center at University of Rochester Medical Center
SUNY Upstate Medical University Hospital
Veterans Affairs Medical Center - Syracuse
Blumenthal Cancer Center at Carolinas Medical Center
Presbyterian Cancer Center at Presbyterian Hospital
Duke Comprehensive Cancer Center
CaroMont Cancer Center at Gaston Memorial Hospital
Leo W. Jenkins Cancer Center at ECU Medical School
High Point Regional Hospital
New Hanover Radiation Oncology, PA
Forsyth Regional Cancer Center at Forsyth Medical Center
Wake Forest University Comprehensive Cancer Center
Summa Center for Cancer Care at Akron City Hospital
Barberton Citizens Hospital
Charles M. Barrett Cancer Center at University Hospital
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland Clinic Taussig Cancer Center
Grandview Hospital
Good Samaritan Hospital
David L. Rike Cancer Center at Miami Valley Hospital
Samaritan North Cancer Care Center
Veterans Affairs Medical Center - Dayton
Middletown Regional Hospital
Cleveland Clinic Cancer Center
Charles F. Kettering Memorial Hospital
Lima Memorial Hospital
Northwest Ohio Oncology Center
Hillcrest Cancer Center at Hillcrest Hospital
St. Charles Mercy Hospital
Cancer Care Center, Incorporated
Flower Hospital Cancer Center
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
UVMC Cancer Care Center at Upper Valley Medical Center
Cancer Treatment Center
Cleveland Clinic - Wooster
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Oklahoma University Cancer Institute
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Willamette Valley Cancer Center - Eugene
Knight Cancer Institute at Oregon Health and Science University
Salem Hospital Regional Cancer Care Services
Celilo Cancer Center at Mid-Columbia Medical Center
Rosenfeld Cancer Center at Abington Memorial Hospital
UPMC Cancer Center at Beaver Medical Center
UPMC Cancer Center at Jefferson Regional Medical Center
Cancer Center at Clarion Hospital
Mercy Fitzgerald Hospital
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Northeast Radiation Oncology Center
UPMC Cancer Center - Arnold Palmer Pavilion
Penn State Cancer Institute at Milton S. Hershey Medical Center
UPMC Cancer Center at the John P. Murtha Pavilion
UPMC Cancer Center at UPMC McKeesport
UPMC - Moon
UPMC Cancer Center - Natrona Heights
Jameson Memorial Hospital - North Campus
Cancer Center of Paoli Memorial Hospital
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase Cancer Center - Philadelphia
UPMC - Shadyside
UPMC Cancer Center at Magee-Womens Hospital
UPMC Cancer Center at UPMC Presbyterian
UPMC Cancer Center at UPMC St. Margaret
UPMC Cancer Center at UPMC Passavant
UPMC Cancer Center - Upper St. Clair
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Guthrie Cancer Center at Guthrie Clinic Sayre
Grand View Hospital
UPMC Cancer Center at UPMC Northwest
UPMC Cancer Center - Uniontown
Washington Hospital Cancer Center
CCOP - Main Line Health
Lankenau Cancer Center at Lankenau Hospital
York Cancer Center at Apple Hill Medical Center
Hollings Cancer Center at Medical University of South Carolina
CCOP - Greenville
CCOP - Upstate Carolina
Thompson Cancer Survival Center
Texas Oncology, PA at Harris Center HEB
St. Joseph Regional Cancer Center
Medical City Dallas Hospital
Texas Oncology, PA at Texas Cancer Center Dallas Southwest
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
M. D. Anderson Cancer Center at University of Texas
Texas Oncology, PA at Texas Cancer Center - Sherman
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Dixie Regional Medical Center - East Campus
Huntsman Cancer Institute at University of Utah
Fletcher Allen Health Care - University Health Center Campus
Community Cancer Center at Rutland Regional Medical Center
Naval Medical Center - Portsmouth
Veterans Affairs Medical Center - Richmond
Virginia Commonwealth University Massey Cancer Center
Providence Cancer Center at Sacred Heart Medical Center
CCOP - Northwest
Madigan Army Medical Center - Tacoma
West Virginia University Health Sciences Center - Charleston
Theda Care Cancer Institute
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
St. Vincent Hospital Regional Cancer Center
Gundersen Lutheran Center for Cancer and Blood
Bay Area Cancer Care Center at Bay Area Medical Center
Community Memorial Hospital Cancer Care Center
Columbia Saint Mary's Hospital - Ozaukee
Columbia-Saint Mary's Cancer Care Center
Medical College of Wisconsin Cancer Center
Veterans Affairs Medical Center - Milwaukee
Vince Lombardi Cancer Clinic - Sheboygan
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Tom Baker Cancer Centre - Calgary
Cross Cancer Institute at University of Alberta
Margaret and Charles Juravinski Cancer Centre
London Regional Cancer Program at London Health Sciences Centre
Ottawa Hospital Regional Cancer Centre - General Campus
Hopital Notre-Dame du CHUM
McGill Cancer Centre at McGill University
Centre Hospitalier Universitaire de Quebec
Allan Blair Cancer Centre at Pasqua Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Androgen suppression + Radiation Therapy

Androgen suppression + Radiation Therapy + Chemotherapy

Arm Description

Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.

Outcomes

Primary Outcome Measures

Overall Survival

Four-year rates are shown. Survival time is defined as time from randomization to 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.

Secondary Outcome Measures

Biochemical Control

Four-year rates are shown (Kaplan-Meier estimates). Biochemical control is defined as freedom from biochemical failure. Biochemical failure was considered as the first of either prostate-specific antigen (PSA) failure or initiation of salvage hormone therapy. PSA failure was defined as a rise of 2 ng/ml over the nadir PSA. Patients who experienced death without biochemical failure, local failure prior to biochemical failure, or development of distant metastases prior to biochemical failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization.

Local Control

Local control is defined as the absence of local failure which is the first of either progression or recurrence within the prostate. Progression of the tumor was considered to have occurred when there was a 25% or greater increase in the product of the two largest perpendicular diameters of the prostate. Recurrence was defined as the reappearance of disease after a complete response. Patients who experienced death without local failure, biochemical failure prior to local failure, and development of distant metastases prior to local failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Due to an insufficient number of events (2 in each arm), this endpoint was not statistically compared. Local control rates at 4 years were calculated using the Kaplan-Meier method.

Distant Metastasis

Distant failure was considered when there was evidence of metastatic disease. Patients who experienced death without distant failure, local failure prior to distant failure, and biochemical failure prior to distant failure were censored on the date of the competing event. The corresponding outcome time was measured from the date of randomization. Distant failure rates at 4 year were calculated using the Kaplan-Meier method.

Disease-free Survival

A failure for disease-free survival is the first of the following: biochemical failure, local failure, distant metastases, or death due to any cause. The corresponding outcome time was measured from the date of randomization. Disease-free survival rates at 4 years were calculated using the Kaplan-Meier method.

Incidence of Adverse Events

Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.

The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level

Biochemical failure is defined as the first of either prostate-specific antigen (PSA) failure or the initiation of salvage hormone therapy. PSA failure is defined as a rise in PSA of 2 ng/ml over the nadir PSA. Distant failure is defined as the first occurrence of distant metastasis.

Validity of PSA Endpoint as a Surrogate for Overall Survival

Prentice's operational criteria for determining whether determining whether biochemical failure (surrogate endpoint) is a suitable endpoint for overall survival (true endpoint): Treatment is prognostic for true endpoint Treatment is prognostic for surrogate endpoint Surrogate is prognostic for true endpoint The full effect of the treatment on the true endpoint is explained by the surrogate. If any of the criteria are not met, it is concluded that biochemical failure is not a suitable surrogate for overall survival. Therefore, if any of the criteria are met, the other criteria do not do not need to be evaluated.

Full Information

NCT ID

NCT00288080

First Posted

February 6, 2006

Last Updated

May 23, 2022

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), NRG Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00288080

Brief Title

Hormone Therapy and Radiation Therapy or Hormone Therapy and Radiation Therapy Followed by Docetaxel and Prednisone in Treating Patients With Localized Prostate Cancer

Official Title

A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT Vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

April 2014 (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), NRG Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may fight prostate cancer by lowering the amount of androgens the body makes. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving hormone therapy and radiation therapy together with chemotherapy is more effective than giving hormone therapy together with radiation therapy in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and radiation therapy followed by docetaxel and prednisone to see how well it works compared to hormone therapy and radiation therapy in treating patients with localized prostate cancer.

Detailed Description

OBJECTIVES: Primary Compare the relative efficacy, in terms of overall survival, of the combination of androgen suppression and radiotherapy versus androgen suppression and radiotherapy followed by docetaxel and prednisone in patients with localized, high-risk prostate cancer. Secondary Compare the disease-free survival and incidence of adverse events in patients treated with these regimens. Compare the biochemical control, local control, and freedom from distant metastases in patients treated with these regimens. Determine the validity of prostate-specific antigen (PSA)-defined endpoints as a surrogate for overall survival of patients treated with these regimens. Compare the time interval between biochemical failure and distant metastases with respect to testosterone level in patients treated with these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to risk group. Arm I: Patients receive androgen suppression therapy comprising luteinizing hormone-releasing hormone (LHRH) agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) and oral antiandrogen (i.e., oral flutamide 3 times daily for 2 months or oral bicalutamide once daily for 2 months). Beginning at week 8, patients undergo radiotherapy 5 days a week for approximately 8 weeks. Antiandrogen therapy is discontinued at completion of radiotherapy, but LHRH agonist therapy continues for 20 months. Arm II: Patients receive androgen suppression therapy and undergo radiotherapy as in arm I. Beginning 4 weeks after completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1 and oral prednisone daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients continue LHRH agonist therapy as in arm I. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.

6. Conditions and Keywords

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

Prostate Cancer

Keywords

stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

612 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Androgen suppression + Radiation Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Androgen suppression + Radiation Therapy + Chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Premedication of dexamethasone prior to docetaxel, per institutional standards.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

10 mg orally per day until day 21 of the last cycle of docetaxel, beginning 28 days after the completion of RT.

Intervention Type

Drug

Intervention Name(s)

docetaxel

Intervention Description

75 mg/m2 i.v. over 1 hour (on day 1 of each cycle) every 21 days for 6 cycles, beginning 28 days after the completion of RT.

Intervention Type

Drug

Intervention Name(s)

Oral antiandrogen

Intervention Description

Oral antiandrogen of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy. Treatment is discontinued at the end of radiation therapy.

Intervention Type

Radiation

Intervention Name(s)

Radiation therapy

Other Intervention Name(s)

3DCRT, Three-dimensional conformal radiotherapy, IMRT, Intensity-modulated radiation therapy

Intervention Description

46.8 Gy, using either three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT), will be given to the regional lymphatics followed by a 25.2-28.8 Gy boost to the prostate, to bring the total dose to the prostate to 72.0-75.6 Gy. Daily prescription doses will be 1.8 Gy per day, 5 days per week x 8-8.5 weeks, beginning 8 weeks after the initiation of androgen suppression.

Intervention Type

Drug

Intervention Name(s)

LHRH agonist

Intervention Description

LHRH agonist of treating institution's choice to be given per package instructions for 8 weeks, then concurrent with radiation therapy, and then until 24 months from initiation of any treatment has been reached.

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Secondary Outcome Measure Information:

Title

Biochemical Control

Description

Time Frame

From randomization to date of biochemical failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Title

Local Control

Description

Time Frame

From randomization to date of local failure, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Title

Distant Metastasis

Description

Time Frame

From randomization to date of distant metastasis, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Title

Disease-free Survival

Description

Time Frame

From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

Title

Incidence of Adverse Events

Description

Adverse events are graded using CTCAE v3.0. The worst grade of all adverse events for each patient is counted.

Time Frame

From start of treatment until the end of follow-up

Title

The Time Interval Between Biochemical Failure and Distant Failure Respect to Testosterone Level

Description

Time Frame

From date of biochemical failure to development of distant metastasis. Maximum follow-up was 12.9 years.

Title

Validity of PSA Endpoint as a Surrogate for Overall Survival

Description

Time Frame

From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 4 years.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: