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

NCT ID: NCT01484808

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Keywords

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PSA Density Prostate Cancer Prostate Biopsy PSA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Urological Associates Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven I Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University Urological Associates Inc.

Locations

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Division of Urology, Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

Central Contacts

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Steven I Cohen, MD

Role: CONTACT

Phone: 4012727799

Email: [email protected]

Samuel Elsamra, MD

Role: CONTACT

Phone: 4014448570

Other Identifiers

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8DUT115799

Identifier Type: -

Identifier Source: org_study_id