An observational study in Prostate Cancer, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-03.
Sponsored by Sunnybrook Health Sciences Centre · Observational
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Subjects are a subset of the men with prostate cancer on surveillance for favorable risk prostate cancer cohort
Inclusion Criteria:
men with favorable risk prostate cancer on surveillance treated with dutasteride
Drug: Dutasteride
dutasteride 0.5mg daily
Also known as: Avodart
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.
Time frame: change from baseline in serum PSA up to secondary rise in serum PSA > 0.5, up to 6 months
rate of secondary rise in serum PSA
Rate of rise in sereum PSA will be correlated with prostate gland volume at initial biopsy.
Time frame: at 6 months after starting dutasteride therapy
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre