Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Overview

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.

Full Title of Study: “Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 2010

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.

Interventions

  • Drug: Dutasteride
    • dutasteride 0.5mg daily

Arms, Groups and Cohorts

  • dutasteride, active surveillance
    • men with favorable risk prostate cancer on surveillance treated with dutasteride

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sunnybrook Health Sciences Centre
  • Collaborator
    • Toronto Sunnybrook Regional Cancer Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Laurence Klotz, Principal Investigator – Sunnybrook Health Sciences Centre
  • Overall Official(s)
    • Laurence Klotz, MD, Principal Investigator, Sunnybrook Health Sciences Centre

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