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

NCT00106691 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1589

Last updated 2023-06-12

Study results available
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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).

Conditions

  • Preneoplastic Conditions
  • Prostatic Intraepithelial Neoplasia

Interventions

DRUG

Toremifene 20 mg

The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).

DRUG

Placebo

The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Sponsors & Collaborators

  • GTx

    lead INDUSTRY

Principal Investigators

  • Samir Taneja, MD · NYU Langone Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States
  • Argentina
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00106691 on ClinicalTrials.gov