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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00684905

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: bicalutamide Drug: leuprolide acetate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Radiation: brachytherapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Feasibility []
Patient tolerance []
Toxicities []
Tumor response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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