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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: bicalutamide
* Drug: leuprolide acetate
* Procedure: adjuvant therapy
* Procedure: neoadjuvant therapy
* Procedure: quality-of-life assessment
* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bicalutamide|nan|
|Drug: leuprolide acetate|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: quality-of-life assessment|nan|
|Radiation: brachytherapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  |  | 
| Patient tolerance |  |  | 
| Toxicities |  |  | 
| Tumor response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer