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

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ClinicalTrials.gov Identifier: NCT01484808
Recruitment Status : Unknown
Verified November 2011 by University Urological Associates Inc..
Recruitment status was:  Not yet recruiting
First Posted : December 2, 2011
Last Update Posted : December 2, 2011
Sponsor:
Information provided by (Responsible Party):
University Urological Associates Inc.

Brief 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).

Condition or disease
Prostate Cancer

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.

Study Type : Observational
Estimated Enrollment : 6600 participants
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
Study Start Date : January 2012
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Dutasteride
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: University Urological Associates Inc.
ClinicalTrials.gov Identifier: NCT01484808     History of Changes
Other Study ID Numbers: 8DUT115799
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: November 2011

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
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs