500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:18 and older
DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Must have one of the following prognostic factors: - Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score > 6 - Stage T1-2, N0; PSA > 10 ng/mL and < 20 ng/mL; and Gleason score ≤ 6 - Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6 - Prostate volume < 60 cc by transrectal ultrasound - No distant or nodal metastases - No metastatic disease by bone scan, CT scan, or MRI PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic: - Bilirubin ≤ 1.5 times upper limit of normal Renal: - Not specified Other: - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy for prostate cancer Chemotherapy: - No prior chemotherapy for prostate cancer Endocrine therapy: - Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy - No other prior hormonal therapy Radiotherapy: - No prior radiotherapy for prostate cancer Surgery: - No prior surgery for prostate cancer - No prior transurethral resection of the prostate Other: - No prior alternative therapy (e.g., PC-SPES) for prostate cancer
Sponsor: Cancer and Leukemia Group B
Phase: Phase 2
Trial ID: NCT00006359
Not Accepting Healthy Volunteers