At a glance
ClinicalIndex Comparison Record- ✓Male aged ≥30 years
- ✓Confirmed high-grade PIN diagnosis from previous prostate biopsy
- ✓Recent prostate biopsy with ≥10 cores in last 6 months showing no cancer, OR 2 biopsies (≥6 cores each) in last 12 months with at least one within 6 months, both negative for cancer
- ✓Serum PSA ≤10 ng/mL
- ✕Previous exposure to toremifene citrate
- ✕Evidence of prostate cancer (local, regional, or distant metastasis)
- ✕History of other malignancies except non-melanoma skin cancer or cancer with no recurrence 5+ years after definitive treatment
- ✕Active systemic viral, bacterial, or fungal infections requiring treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
In Brief
A Phase 3 clinical trial evaluating Toremifene 20 mg and Placebo for Preneoplastic Conditions and Prostatic Intraepithelial Neoplasia. Completed, enrolled 1,589 participants across 138 sites in 3 countries.
Detailed Summary
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
Study Details
Timeline
Interventions
The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.