Response of Patients on Surveillance for Prostate Cancer to Dutasteride

NCT01525914 | Completed

• 1 other identifier: CRT114918
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; PSA kinetics; PSA doubling time; active surveillance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• rate of secondary rise in serum PSA

  at 6 months after starting dutasteride therapy

Study Arms (1)

dutasteride, active surveillance

men with favorable risk prostate cancer on surveillance treated with dutasteride

Drug: Dutasteride

Interventions

Dutasteride DRUG

dutasteride 0.5mg daily

Also known as: Avodart

dutasteride, active surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Toronto Sunnybrook Regional Cancer Centre: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

prostate biopsy tissue stored on site

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Laurence Klotz, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: February 3, 2012
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

CA (1)