Clinical trial NCT01428869: Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer
Official title: The Effect of Combination Statin, Acetylsalicylic Acid and Dutasteride Use on Prostate Cancer - a Sub Analysis of the REDUCE Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Statins
acetylsalicylic acid
dutasteride
Prostate Cancer
Lower urinary tract symptoms
prevention
drug interactions
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 8231
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Diagnosis of Prostate Cancer
timeFrame: 4 years
Secondary outcomes:
measure: Diagnosis of High Grade Prostate Cancer
timeFrame: 4 years
measure: Improvement of Lower Urinary Tract Symptoms
timeFrame: 4 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Neil E Fleshner, MD MPH FRCSC
role: PRINCIPAL_INVESTIGATOR
References: