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
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Arm I
Experimental
Patients receive oral selenomethionine and oral finasteride once daily for 4-5 weeks.
Arm II
Experimental
Patients receive oral placebo and oral finasteride once daily for 4-5 weeks.
Arm III
Experimental
Patients receive oral selenomethionine and oral placebo once daily for 4-5 weeks.
Arm IV
Placebo Comparator
Patients receive two oral placebos once daily for 4-5 weeks.
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 except nonmelanoma skin cancer
- Willing and able to take finasteride, selenomethionine, and/or placebo for 4-5 weeks
prior to prostatectomy/brachytherapy
PRIOR CONCURRENT THERAPY:
- More than 1 year since prior finasteride, dutasteride, Sereona repens (saw palmetto),
or any other 5-? 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-? 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)
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
