Response of Patients on Surveillance for Prostate Cancer to Dutasteride

This study has been completed.
Sponsor:
Collaborator:
Odette Cancer Centre Genito-Urinary Disease Site Group
Information provided by (Responsible Party):
Dr. Laurence Klotz, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01525914
First received: September 22, 2011
Last updated: February 2, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Dutasteride

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome 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 ] [ 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.


Secondary Outcome Measures:
  • 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


Enrollment: 100
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dutasteride, active surveillance
men with favorable risk prostate cancer on surveillance treated with dutasteride
Drug: Dutasteride
dutasteride 0.5mg daily
Other Name: Avodart

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects are a subset of the men with prostate cancer on surveillance for favorable risk prostate cancer cohort

Criteria

Inclusion Criteria:

  • Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525914

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Odette Cancer Centre Genito-Urinary Disease Site Group
Investigators
Principal Investigator: Laurence Klotz, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Laurence Klotz, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01525914     History of Changes
Other Study ID Numbers: CRT114918
Study First Received: September 22, 2011
Last Updated: February 2, 2012
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
prostate cancer
PSA kinetics
PSA doubling time
active surveillance

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014