A Randomized, Double Blind, Placebo Controlled Clinical Trial of L-SeMet Supplementation and Finasteride Treatment of Patients With Prostate Cancer Prior to Robotic Prostatectomy/Brachytherapy
Overview
- Phase
- Phase 2
- Intervention
- selenomethionine
- Conditions
- Prostate Cancer
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Effects of Selenium and Finasteride and Their Combination on PSA Level
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
RATIONALE: Selenomethionine may slow the growth of prostate cancer. Testosterone can cause the growth of prostate cancer cells. Finasteride may fight prostate cancer by lowering the amount of testosterone the body makes. Giving selenomethionine together with finasteride before surgery or radiation therapy may be an effective treatment for prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenomethionine and finasteride work when given before surgery or radiation therapy in treating patients with stage I or stage II prostate cancer.
Detailed Description
OBJECTIVES: Primary * To investigate the effects of selenomethionine and/or finasteride on key androgen receptor signaling biomarkers (prostate-specific antigen, kallikrein 2, and NKX3.1) in prostate tissue samples from patients with stage I or II prostate cancer. Secondary * To analyze the effects of selenomethionine and/or finasteride on apoptosis induction in benign prostate tissue samples from these patients. Tertiary * To determine whether responsiveness to selenomethionine and/or finasteride is related to the level of Prx1 in prostate cancer cells. OUTLINE: Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy. * Arm II: Patients receive oral placebo and oral finasteride once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy. * Arm III: Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy. * Arm IV: Patients receive two oral placebos once daily for 4-5 weeks. Patients then undergo prostatectomy or brachytherapy. Blood samples are collected at baseline and on the day of prostatectomy or brachytherapy. Samples are analyzed for testosterone and 5-α-dihydrotestosterone levels by capillary gas chromatography-mass spectrometry; genetic polymorphisms in the type 2 5-α reductase gene by PCR and sequencing analyses; and selenium levels by atomic absorption spectrophotometry. Additional blood samples will be stored for future analysis of alpha and gamma tocopherol, lycopene, and other vitamin levels. Toenail samples are also collected to provide an indicator of long-term selenium status. Prostate tissue samples are collected during and after prostatectomy or prior to brachytherapy. Samples are analyzed for expression of biomarkers (e.g., prostate-specific antigen, kallikrein 2, and NKX 3.1) by quantitative RT-PCR and apoptosis by TUNEL assay, immunohistochemistry, and ELISA.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Intervention: selenomethionine
Arm I
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Intervention: finasteride
Arm II
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Intervention: finasteride
Arm II
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Intervention: placebo
Arm III
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Intervention: selenomethionine
Arm III
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Intervention: placebo
Arm IV
Patients receive two oral placebos once daily for 4-5 weeks.
Intervention: placebo
Outcomes
Primary Outcomes
Effects of Selenium and Finasteride and Their Combination on PSA Level
Time Frame: 1 year
Compare PSA levels with Finasteride Placebo + Selenium Placebo group (Arm C). The Wilcoxon Rank Sum Test was used to test the difference of PSA levels of Arm A, Arm B, Arm D with Arm C.
Secondary Outcomes
- Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction(1 year)