At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of high-grade prostatic intraepithelial neoplasia (HGPIN) confirmed by prostate biopsy with no evidence of cancer
- ✓Biopsy requirements: fewer than 10 cores within past 24 months, OR 10+ cores within past 6 months, OR 10+ cores 6-24 months before study
- ✓Age 40 years or older
- ✓PSA ≤10 ng/mL (≤5 ng/mL if finasteride or other androgen suppressor used within past 2 months)
- ✕Biopsy with fewer than 6 cores requires transrectal ultrasound-guided repeat biopsy; patients not meeting adequate biopsy criteria are excluded
- ✕Any malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I-II cancer in complete remission
- ✕Concurrent finasteride or other androgen suppressors
- ✕Concurrent daily dietary supplements containing >50 micrograms of selenium
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
In Brief
A Phase 3 clinical trial evaluating L-selenomethionine and L-selenomethionine placebo for Precancerous/Nonmalignant Condition and Prostate Cancer. Completed, enrolled 619 participants.
Detailed Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate. PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.
Study Details
Timeline
Interventions
Randomization between active L-selenomethionine and placebo
Randomization between active L-selenomethionine and placebo