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Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia) | Clinical Trials | Clareo Health

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

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)

NCT00106691•GTx

View on ClinicalTrials.gov

Summary

Detailed Description

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. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.

Eligibility

Age

30 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Give voluntary signed informed consent in accordance with institutional policies
•Be male, aged ≥ 30 years
•Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist
•Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist
•Have a serum PSA of ≤ 10 ng/mL
•Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake
•Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication
•Have adequate bone marrow, liver and renal function:
•* White Blood Cell (WBC) Count ≥ 3,000/mm3;
•* Platelet Count ≥ 100,000/mm3;
+9 more criteria

Exclusion Criteria

•Previous exposure to toremifene citrate
•Have evidence of prostate cancer (local, regional and/or distal metastasis)
•Have any history of other malignancies (Exceptions include non-melanoma skin cancer or other cancer that has no evidence of tumor reoccurrence 5 years after definitive treatment).
•Have active systemic viral, bacterial, or fungal infections requiring treatment
•Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
•Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening

Locations (138)

Medical Affiliated Research Ctr.

Huntsville, Alabama, United States

Coastal Clinical Research

Mobile, Alabama, United States

Hope Research Inst.

Phoenix, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

San Bernardino Urological Associates Medical Group

San Bernardino, California, United States

Western Clinical Research, Inc.

Torrance, California, United States

Urology Research Options

Aurora, Colorado, United States

Urology Associates, P.C.

Denver, Colorado, United States

The Urology Center of Colorado

Denver, Colorado, United States

Connecticut Surgical Group

Hartford, Connecticut, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

February 1, 2010

Completion Date

February 1, 2010

Last Updated

June 12, 2023

Enrollment

1,589

ACTUAL participants

Conditions

Preneoplastic ConditionsProstatic Intraepithelial Neoplasia

Interventions

Toremifene 20 mg

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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