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The Effect of Combination Statin, Acetylsalicylic Acid and Dutasteride Use on Prostate Cancer - a Sub Analysis of the REDUCE Trial

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Trial Information

The Effect of Combination Statin, Acetylsalicylic Acid and Dutasteride Use on Prostate Cancer - a Sub Analysis of the REDUCE Trial

A review of data collected from REDUCE (REduction by DUtasteride of prostate Cancer Events)
study participants will be performed. Data required for the analysis includes: ethnicity,
prostate specific antigen (PSA) levels, prostate volumes, presence of diabetes, concomitant
medication use (for statin and ASA), prostate biopsy results at 2 and 4 years, body mass
index (BMI), digital rectal exam (DRE) results, family history of Prostate Cancer and benign
prostatic hyperplasia (BPH) outcomes: urinary retention, international prostate symptom
score (IPSS), urinary tract infections (UTI)s.

The association of drug interactions with prostate cancer will be explored by using a
multivariate logistic regression model including all possible interaction terms between
dutasteride, ASA and statins (i.e. statin+ASA+dutasteride, statin+ASA, dutasteride+statin,
dutasteride+ASA). Any interaction term found to be insignificant ( i.e. p>0.05) will be
removed from the model. If a statistically significant interaction term is identified, the
study cohort will be stratified by drug use, and the relative risk (RR)of prostate cancer
among the different drug users will be reported. To control for potential confounders, a
multivariate regression model will be constructed adjusting for age, family history of
prostate cancer, DRE results and BMI.

Inclusion Criteria:

- Participants who received dutasteride or placebo and had at least one post-baseline
prostate biopsy

Exclusion Criteria:

- Participants not taking concomitant statins or ASA

Type of Study:


Study Design:

Time Perspective: Retrospective

Outcome Measure:

Diagnosis of Prostate Cancer

Outcome Description:

The relative risk of prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Neil E Fleshner, MD MPH FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:




Start Date:

August 2011

Completion Date:

August 2011

Related Keywords:

  • Prostate Cancer
  • Statins
  • acetylsalicylic acid
  • dutasteride
  • Prostate Cancer
  • Lower urinary tract symptoms
  • prevention
  • drug interactions
  • Prostatic Neoplasms