Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: LHRH agonistDrug: antiandrogenRadiation: radiation therapyRadiation: Brachytherapy boost
- Registration Number
- NCT00006359
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
- Detailed Description
OBJECTIVES:
* Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
* Determine the safety of EBRT+BT in these patients.
* Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.
OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.
Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 63
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Androgen suppression + EBRT + Brachytherapy radiation therapy Androgen suppression with external beam radiation therapy followed by brachytherapy boost Androgen suppression + EBRT + Brachytherapy Brachytherapy boost Androgen suppression with external beam radiation therapy followed by brachytherapy boost Androgen suppression + EBRT + Brachytherapy LHRH agonist Androgen suppression with external beam radiation therapy followed by brachytherapy boost Androgen suppression + EBRT + Brachytherapy antiandrogen Androgen suppression with external beam radiation therapy followed by brachytherapy boost
- Primary Outcome Measures
Name Time Method Toxicity q 3 mon for 2 yrs post tx initiation
- Secondary Outcome Measures
Name Time Method Time to PSA failure 6 years Survival 6 years Progression free and overall survival will be assessed
Trial Locations
- Locations (26)
Hudner Oncology Center at Saint Anne's Hospital
🇺🇸Fall River, Massachusetts, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Union Hospital Cancer Center at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
St. Francis Hospital
🇺🇸Wilmington, Delaware, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Washoe Cancer Services at Washoe Medical Center - Reno
🇺🇸Reno, Nevada, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
🇺🇸Camden, New Jersey, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Community General Hospital of Greater Syracuse
🇺🇸Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Arch Medical Services, Incoroporated at Center for Cancer Care Research
🇺🇸Saint Louis, Missouri, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States