Response of Patients on Surveillance for Prostate Cancer to Dutasteride
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|ClinicalTrials.gov Identifier: NCT01525914|
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : February 3, 2012
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 or disease||Intervention/treatment|
|Prostate Cancer||Drug: Dutasteride|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Assessment of Response of Patients on Surveillance for Favorable Risk Prostate Cancer to Dutasteride|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
dutasteride, active surveillance
men with favorable risk prostate cancer on surveillance treated with dutasteride
dutasteride 0.5mg daily
Other Name: Avodart
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525914
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Laurence Klotz, MD||Sunnybrook Health Sciences Centre|