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"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Prevention Closed 50 to 75 Pharmaceutical / Industry ARI40006
NCT00056407

Trial Description

Summary

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Eligibility Criteria

Inclusion criteria:

Informed consent to participate in study.

Have had a single negative prostate biopsy within 6 months prior to enrollment in study.

Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.

Ability and will to participate in study for 4 years.

Exclusion criteria:

More than one previous negative prostate biopsy.

History of prostate cancer.

Previous prostate surgery.

Inability to urinate requiring the need of a catheter during the previous 2 years.

Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.

Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).

Any unstable serious medical condition.

Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.

Trial Contact Information

Trial Lead Organizations/Sponsors

GlaxoSmithkline

GSK Clinical Trials, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00056407
Information obtained from ClinicalTrials.gov on May 11, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.