Status:
COMPLETED
Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 testoste...
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 prostat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven adenocarcinoma of the prostate
- Diagnosed by sextant or greater biopsy
- Clinical stage \< T3 (stage I or II) disease
- Prostate-specific antigen \< 20.0 ng/mL
- Gleason score \< 8
- Scheduled to undergo prostatectomy or brachytherapy
- PATIENT CHARACTERISTICS:
- Life expectancy \> 5 years
- No other prior malignancy (excluding nonmelanoma skin cancer) in the past 5 years
- Willing and able to take finasteride, selenomethionine, and/or placebo for 3-5 weeks prior to prostatectomy/brachytherapy
- PRIOR CONCURRENT THERAPY:
- More than 1 year since prior finasteride, dutasteride, Sereona repens (saw palmetto), or any other 5-α reductase inhibitor
- No prior hormonal therapy or radiotherapy
- More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modification or exercise)
- No concurrent selenium dietary supplement at doses \> 200 mg/day, including multivitamin supplements
- At least 30 days since \> 200mg/day of prior selenium dietary supplement
- No other concurrent hormonal therapy, including 5-α reductase inhibitors (e.g., finasteride or dutasteride); anti-androgens (e.g., bicalutamide, flutamide, or ketoconazole); or luteinizing hormone-releasing hormone agonists (e.g., leuprolide acetate, goserelin acetate, or abarelix)
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00736645
Start Date
August 1 2008
End Date
December 1 2012
Last Update
October 2 2023
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001