Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy

OBJECTIVES:

• Determine the feasibility and patient tolerance of interstitial brachytherapy combined with androgen-deprivation therapy for patients with locally recurrent prostate cancer after prior external-beam irradiation.
• Determine the toxicity of interstitial brachytherapy combined with androgen-deprivation therapy in these patients.
• Determine the tumor response to interstitial brachytherapy combined with androgen-deprivation therapy in these patients.

OUTLINE: Patients receive neoadjuvant therapy comprising leuprolide acetate intramuscularly for 3 months and oral bicalutamide once daily for 30 days, beginning on the first day of leuprolide acetate administration. Patients then undergo interstitial brachytherapy implantation with I-125. Following brachytherapy, patients receive adjuvant leuprolide acetate every 3 months for an additional 6 months.

Quality of life is assessed at baseline and at every treatment and follow-up visit.

After completion of study therapy, patients are followed every 3 months for 2 years, every to 4-6 months for 3 years, and then annually thereafter.

DISEASE CHARACTERISTICS:

• Biopsy-proven adenocarcinoma of the prostate

• Locally recurrent disease, defined by digital rectal examination and/or rising prostate-specific antigen (PSA)
• No evidence of nodal or distant metastasis (i.e., N0, M0) on physical examination, bone scan, or CT scan of the pelvis
• Clinical stage T1c-T3a disease at the time of recurrence
• PSA < 10 ng/mL
• Prostate volume by transrectal ultrasonography < 60 cc
• Received prior external beam radiotherapy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• WBC ≥ 3,000/μL
• Platelet count ≥ 90,000/μL
• Hemoglobin ≥ 10 g/dL
• Alkaline phosphatase < 2 times normal
• AST < 2 times normal
• Normal prothrombin time and partial thromboplastin time
• No significant obstructive urinary symptoms (AUA score ≤ 16)
• No contraindication for general anesthesia

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior transurethral resection of the prostate