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

Completed · Phase 3 · Has a placebo group

Conditions studied: Neoplasms, Prostate

In brief

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.

Key facts

Study ID

NCT00056407

Run by

GlaxoSmithKline

People needed

8231

Starts

2003-03-01

Expected to finish

2009-04-01

Last updated by the study team

2016-09-23

Who can join

Age: 50 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Homewood, Alabama, United States
• GSK Investigational Site — Huntsville, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Anchorage, Alaska, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Sun City, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Atherton, California, United States
• GSK Investigational Site — Culver City, California, United States
• GSK Investigational Site — Encino, California, United States
• GSK Investigational Site — Fountain Valley, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — La Mesa, California, United States
• GSK Investigational Site — Laguna Hills, California, United States
• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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