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Combination Statin, Acetylsalicylic Acid and Dutasteride Use in Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01428869
First received: August 26, 2011
Last updated: September 8, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 8231
Study Start Date: August 2011
Study Completion Date: August 2011
Groups/Cohorts
statin+ASA+dutasteride
statin+ASA
dutasteride+statin
dutasteride+ASA

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428869

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Neil E Fleshner, MD MPH FRCSC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01428869     History of Changes
Other Study ID Numbers: 10-1000AE
Study First Received: August 26, 2011
Last Updated: September 8, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Statins
acetylsalicylic acid
dutasteride
Prostate Cancer
 Lower urinary tract symptoms
prevention
drug interactions

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Aspirin
Dutasteride
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013