Trial record 7 of 50 for:    prostate cancer prevention | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Urological Associates Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
University Urological Associates Inc.
ClinicalTrials.gov Identifier:
NCT01484808
First received: November 30, 2011
Last updated: December 1, 2011
Last verified: November 2011
  Purpose

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).


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by University Urological Associates Inc.:

Estimated Enrollment: 6600
Study Start Date: January 2012
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men with PSA elevation (>=4), 50-74 years old with negative biopsy of the prostate at study entry

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484808

Contacts
Contact: Steven I Cohen, MD 4012727799 ext 1232 sicppmd@cox.net
Contact: Samuel Elsamra, MD 4014448570

Locations
United States, Rhode Island
Division of Urology, Brown University Not yet recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Steven I Cohen, MD         
Sponsors and Collaborators
University Urological Associates Inc.
Investigators
Principal Investigator: Steven I Cohen, MD University Urological Associates Inc.
  More Information

No publications provided

Responsible Party: University Urological Associates Inc.
ClinicalTrials.gov Identifier: NCT01484808     History of Changes
Other Study ID Numbers: 8DUT115799
Study First Received: November 30, 2011
Last Updated: December 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University Urological Associates Inc.:
PSA Density
Prostate Cancer
Prostate Biopsy
PSA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014