Prostate Cancer Clinical Trial
Official title:
Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy,
such as leuprolide and bicalutamide, may lessen the amount of androgens made by the body.
Implant radiation therapy kills tumor cells by placing material such as radioactive iodine
directly into or near a tumor. Giving leuprolide and bicalutamide together with implant
radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving leuprolide and
bicalutamide together with implant radiation therapy and to see how well it works 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.
;
Primary Purpose: Treatment
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