Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Dutasteride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on active surveillance for favorable risk prostate cancer who have been treated with dutasteride following the diagnosis of cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dutasteride, active surveillance<br>men with favorable risk prostate cancer on surveillance treated with dutasteride | Drug: Dutasteride<br>* dutasteride 0.5mg daily<br>* Other names: Avodart;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, PSA kinetics, PSA doubling time, active surveillance