Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525914
• Other study ID #: CRT114918
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: February 2, 2012
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: February 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Dutasteride
dutasteride 0.5mg daily

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Toronto Sunnybrook Regional Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	rate of secondary rise in serum PSA	Rate of rise in sereum PSA will be correlated with prostate gland volume at initial biopsy.	at 6 months after starting dutasteride therapy	No