Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- change in serum PSA
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
dutasteride, active surveillance
men with favorable risk prostate cancer on surveillance treated with dutasteride
Intervention: Dutasteride (Drug)
Outcomes
Primary Outcomes
change in serum PSA
Time Frame: 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 Outcomes
- rate of secondary rise in serum PSA(at 6 months after starting dutasteride therapy)
Investigators
Dr. Laurence Klotz
Principal Investigator
Sunnybrook Health Sciences Centre