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Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

change in serum PSA

Outcome Description:

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.

Outcome Time Frame:

change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months

Safety Issue:


Principal Investigator

Laurence Klotz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sunnybrook Health Sciences Centre


Canada: Health Canada

Study ID:




Start Date:

May 2010

Completion Date:

August 2010

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • PSA kinetics
  • PSA doubling time
  • active surveillance
  • Prostatic Neoplasms