Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Dutasteride

• Registration Number: NCT01525914
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

Hypothesis: That, in men on surveillance for favorable risk prostate cancer treated with dutasteride, prostate specific antigen (PSA) kinetics is of value in identifying those men who harbor occult high grade prostate cancer.

The study will determine the prevalence of a secondary rise in PSA \> 0.5 ng/ml and the PSA doubling time in subjects on surveillance being treated with dutasteride.

Detailed Description

This analysis is a subset of the data associated with the active surveillance cohort at Sunnybrook Health Sciences Centre. Approximately 150 subjects within the cohort have received dutasteride therapy from 6 months to 3 years. All subjects have had serial PSAs at regular intervals between 3 to 6 months, and all have had a biopsy performed within 1 to 3 years of initiating dutasteride. The prevalence of a secondary rise in PSA \> 0.5ng/ml will be calculated with the impact of dutasteride therapy on the PSA doubling time. This information will be correlated with baseline PSA value, prostate volume, extent of disease on initial biopsy and baseline PSA kinetics. PSA kinetics will be also correlated with Gleason score upgrading on repeat biopsy. The rate of negative biopsies in men on dutasteride therapy will be compared with a similar group of surveillance subjects not treated with dutasteride.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2011-09-22
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-02
• Last Update Submitted: 2012-02-02
• Study First Posted: 2012-02-03
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dutasteride, active surveillance	Dutasteride	men with favorable risk prostate cancer on surveillance treated with dutasteride

Primary Outcome Measures

Name	Time	Method
change in serum PSA	change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months	The time that the change in serum PSA from baseline to the secondary rise will be used to determine the PSA 'kinetics' in men on surveillance for prostate cancer.

Secondary Outcome Measures

Name	Time	Method
rate of secondary rise in serum PSA	at 6 months after starting dutasteride therapy	Rate of rise in sereum PSA will be correlated with prostate gland volume at initial biopsy.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada