The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
PSA Density, Prostate Cancer, Prostate Biopsy, PSA
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Retrospective
Overall Status
Not yet recruiting
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).
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 74 Years
Minimum Age: 50 Years
Gender: Male
Criteria: 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
Location
Division of Urology, Brown University
Providence, Rhode Island, United States
Status: Not yet recruiting
Start Date
January 2012
Completion Date
May 2012
Sponsors
University Urological Associates Inc.
Source
University Urological Associates Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page