Selenomethionine and Finasteride Before Surgery or Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
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.
Timeline
- Start
- 2008-08
- Primary completion
- 2012-12
- Completion
- 2012-12
Outcome
Missed primary endpoint
registry analysis (other test); Arm A: Finasteride + Selenium Placebo vs Arm C: Finasteride Placebo + Selenium Placebo; p = 0.5137; Wilcoxon (Mann-Whitney) NCT00736645 ↗
registry analysis (other test); Arm B: Finasteride + Selenium vs Arm C: Finasteride Placebo + Selenium Placebo; p = 0.8994; Wilcoxon (Mann-Whitney) NCT00736645 ↗
registry analysis (other test); Arm C: Finasteride Placebo + Selenium Placebo vs Arm D: Finasteride Placebo + Selenium; p = 0.3463; Wilcoxon (Mann-Whitney) NCT00736645 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Finasteride | Small molecule | — | Oral |