Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

Phase 3 Completed 1589 enrolled GTx

RandomizedParallel-groupTriple-blindPrevention

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).

Timeline

Start: 2005-01
Primary completion: 2010-02
Completion: 2010-02

Outcome

Missed primary endpoint

paper Cancer was detected in 34.7% and 32.3% of men in the placebo and treatment groups, respectively, with no observed difference (P = .39, log-rank test) PMID 23295793 ↗

Publications

Taneja SS, Morton R, Barnette G, Sieber P, Hancock ML, Steiner M. Prostate cancer diagnosis among men with isolated high-grade intraepithelial neoplasia enrolled onto a 3-year prospective phase III clinical trial of oral toremifene. J Clin Oncol. 2013 Feb 10;31(5):523-9. doi: 10.1200/JCO.2012.41.7634. Epub 2013 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Toremifene	Small molecule	20 mg	Oral