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
50 Years
75 Years
Male
Neoplasms, Prostate
Trial Information
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
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
Outcome Description:
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.
Outcome Time Frame:
Years 1-2, Years 3-4, and Overall (Years 1-4)
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
Canada: Health Canada
Study ID:
ARI40006
NCT ID:
NCT00056407
Start Date:
March 2003
Completion Date:
May 2009
Related Keywords:
- Neoplasms, Prostate
- Prostate cancer prevention
- prostate
- BPH
- enlarged prostate
- PSA
- prostate cancer
- Neoplasms
- Prostatic Neoplasms
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