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Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Dutasteride (Drug)

Phase: N/A

Status: Completed

Sponsored by: Sunnybrook Health Sciences Centre

Official(s) and/or principal investigator(s):
Laurence Klotz, MD, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: change in serum PSA

Secondary outcome: rate of secondary rise in serum PSA

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Patients on active surveillance for favorable risk prostate cancer who have been

treated with dutasteride following the diagnosis of cancer.

Locations and Contacts

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada
Additional Information

Starting date: May 2010
Last updated: February 2, 2012

Page last updated: August 20, 2015

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