Leuprolide, Bicalutamide, and Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer After External-Beam Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00684905|
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : November 12, 2012
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|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||Phase II Interstitial Brachytherapy Combined With Androgen Deprivation Therapy for Locally Recurrent Prostate Cancer After Prior External Beam Irradiation|
|Study Start Date :||April 2000|
|Primary Completion Date :||October 2005|
|Study Completion Date :||October 2005|
- Patient tolerance
- Tumor response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684905
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|Study Chair:||William W. Wong, MD||Mayo Clinic|