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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2
flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks
4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)
Toxicity
Time frame: q 3 mon for 2 yrs post tx initiation
Time to PSA failure
Time frame: 6 years
Survival
Progression free and overall survival will be assessed
Time frame: 6 years
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Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital
Fall River, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
...and 16 more locations