Response of Patients on Surveillance for Prostate Cancer to Dutasteride
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride|
- 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 ] [ Designated as safety issue: No ]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.
- rate of secondary rise in serum PSA [ Time Frame: at 6 months after starting dutasteride therapy ] [ Designated as safety issue: No ]Rate of rise in sereum PSA will be correlated with prostate gland volume at initial biopsy.
Biospecimen Retention: Samples With DNA
prostate biopsy tissue stored on site
|Study Start Date:||May 2010|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
dutasteride, active surveillance
men with favorable risk prostate cancer on surveillance treated with dutasteride
dutasteride 0.5mg daily
Other Name: Avodart
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525914
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Laurence Klotz, MD||Sunnybrook Health Sciences Centre|