"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk (REDUCE)
Neoplasms, Prostate
About this trial
This is an interventional prevention trial for Neoplasms, Prostate focused on measuring Prostate cancer prevention, prostate, BPH, enlarged prostate, PSA, prostate cancer
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo Arm
dustasteride arm
Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio.
Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center.