Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer
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 Design:||Time Perspective: Retrospective|
|Official Title:||The Effect of Combination Statin, Acetylsalicylic Acid and Dutasteride Use on Prostate Cancer - a Sub Analysis of the REDUCE Trial|
- Diagnosis of Prostate Cancer [ Time Frame: 4 years ] [ Designated as safety issue: No ]The relative risk of prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride.
- Diagnosis of High Grade Prostate Cancer [ Time Frame: 4 years ] [ Designated as safety issue: No ]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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]The impact of combination statin, acetylsalicylic acid and dutasteride use on lower urinary tract symptoms in REDUCE study participants.
Biospecimen Retention: Samples Without DNA
Specimens were retained as part of the REDUCE protocol, but no biospecimens are required for the current protocol.
|Study Start Date:||August 2011|
|Study Completion Date:||August 2011|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428869
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Neil E Fleshner, MD MPH FRCSC||University Health Network, Toronto|