Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01428869
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-08-26
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-05
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8231

Inclusion Criteria

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

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Exclusion Criteria

• Participants not taking concomitant statins or ASA

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of Prostate Cancer	4 years	The relative risk of prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride.

Secondary Outcome Measures

Name	Time	Method
Diagnosis of High Grade Prostate Cancer	4 years	The relative risk of high grade prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride
Improvement of Lower Urinary Tract Symptoms	4 years	The impact of combination statin, acetylsalicylic acid and dutasteride use on lower urinary tract symptoms in REDUCE study participants.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada