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Not Recruiting
Trial ID: NCT00056407
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Kathryn Simmons Stamey Professor, Emeritus
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.
drug: Dutasteride
drug: Placebo
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kristin Hirabayashi
6507361362