Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer

Condition(s) targeted: Prostate Cancer

Phase: N/A

Status: Completed

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Neil E Fleshner, MD MPH FRCSC, Principal Investigator, Affiliation: University Health Network, Toronto

The purpose of this study is to assess whether there is any interaction between statins, acetylsalicylic acid (ASA) and dutasteride on protection from prostate cancer, the development of high grade prostate cancer, or lower urinary tract symptoms.

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

Study design: Time Perspective: Retrospective

Primary outcome: Diagnosis of Prostate Cancer

Secondary outcome:

Diagnosis of High Grade Prostate Cancer

Improvement of Lower Urinary Tract Symptoms

Detailed description: 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

Criteria:

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

University Health Network, Toronto, Ontario M5G 2M9, Canada

Starting date: August 2011
Last updated: September 8, 2011