The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage

Prostate Cancer Clinical Trial

— PSADv  

Official title:

Retrospective Review of Reduce Data to Determine the Utility of PSADv While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01484808
• Other study ID #: 8DUT115799
• Status: Not yet recruiting
• Phase: N/A
• First received: November 30, 2011
• Last updated: December 1, 2011
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: November 2011
• Source: University Urological Associates Inc.
• Contact: Steven I Cohen, MD
• Phone: 4012727799
• Email: sicppmd[@]cox.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is a review of previously published data from a large prostate cancer prevention study known as REDUCE. It is the investigators intention to review whether prostate specific antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity).

Description:

This is a review of previously published data from a large prostate cancer prevention study known as REDUCE that utilized a 5 ARI, dutasteride. It is the investigators intention to review whether PSA velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity) by two year biopsy. The investigator will review and compare data to a previously published study of similar design with finasteride.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6600
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• Men,

• 50-74 years old with elevated PSA (>=4) along with negative entry biopsy of the prostate who had a subsequent biopsy by 24 months.

Exclusion Criteria:

• Any positive biopsy of the prostate indicative of cancer upon entry

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Division of Urology, Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
University Urological Associates Inc.

Country where clinical trial is conducted

United States,