NCT01428869

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
Last Updated

September 9, 2011

Status Verified

September 1, 2011

First QC Date

August 26, 2011

Last Update Submit

September 8, 2011

Conditions

Prostate Cancer

Keywords

Statinsacetylsalicylic aciddutasterideProstate CancerLower urinary tract symptomspreventiondrug interactions

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of Prostate Cancer

    The relative risk of prostate cancer development in REDUCE study participants treated with a combination of statins, acetylsalicylic acid and dutasteride.

    4 years

Secondary Outcomes (2)

  • Diagnosis of High Grade Prostate Cancer

    4 years

  • Improvement of Lower Urinary Tract Symptoms

    4 years

Study Arms (4)

statin+ASA+dutasteride

statin+ASA

dutasteride+statin

dutasteride+ASA

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Participants not taking concomitant statins or ASA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens were retained as part of the REDUCE protocol, but no biospecimens are required for the current protocol.

MeSH Terms

Conditions

Prostatic NeoplasmsLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neil E Fleshner, MD MPH FRCSC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

September 5, 2011

Study Start

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 9, 2011

Record last verified: 2011-09

Locations

CA(1)