Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride
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.
Observational
Observational Model: Cohort, Time Perspective: Retrospective
change in serum PSA
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.
change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months
No
Laurence Klotz, MD
Principal Investigator
Sunnybrook Health Sciences Centre
Canada: Health Canada
CRT114918
NCT01525914
May 2010
August 2010
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