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

U

University Urological Associates Inc.

Status

Unknown

Conditions

Prostate Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT01484808
8DUT115799

Details and patient eligibility

About

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).

Full 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.

Enrollment

6,600 estimated patients

Sex

Male

Ages

50 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Samuel Elsamra, MD; Steven I Cohen, MD

Data sourced from clinicaltrials.gov

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