Phase 2
Completed N=55
Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Source: ClinicalTrials.gov NCT00736645 ↗Enrolled (actual)
55
Serious AEs
9.1%
Results posted
Nov 2017
Primary outcomePrimary: Effects of Selenium and Finasteride and Their Combination on PSA Level — 1.9; 1.9; 2.0; 2.1 ng/mL — p=0.5137
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Selenium and Finasteride and Their Combination on PSA Level |
1.9; 1.9; 2.0; 2.1 | 0.5137 |
| SECONDARY Effects of Selenium and Finasteride and Their Combination on Apoptosis Induction |
0.1; 0; 0; 0 | 0.2609 |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically proven adenocarcinoma of the prostate
- Diagnosed by sextant or greater biopsy
- Clinical stage 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)
Data sourced from ClinicalTrials.gov (NCT00736645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.