Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer

September 8, 2011 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Prostate Cancer

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 Type

Observational

Enrollment (Actual)

8231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Participants of the REDUCE trial (negative prostate biopsy at baseline) who had at least one post-baseline prostate biopsy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
statin+ASA+dutasteride
statin+ASA
dutasteride+statin
dutasteride+ASA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of High Grade Prostate Cancer Time Frame: 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	4 years
Improvement of Lower Urinary Tract Symptoms Time Frame: 4 years	The impact of combination statin, acetylsalicylic acid and dutasteride use on lower urinary tract symptoms in REDUCE study participants.	4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

Principal Investigator: Neil E Fleshner, MD MPH FRCSC, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 26, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

September 9, 2011

Last Update Submitted That Met QC Criteria

September 8, 2011

Last Verified