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

Retrospective Review of Reduce Data to Determine the Utility of PSADv While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01484808

Acronym

PSADv

Enrollment

6600

Registered

2011-12-02

Start date

2012-01-31

Completion date

2012-05-31

Last updated

2011-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

PSA Density, Prostate Cancer, Prostate Biopsy, PSA

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).

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to 74 Years

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

Countries

United States

Contacts

Primary ContactSteven I Cohen, MD

sicppmd@cox.net4012727799

Backup ContactSamuel Elsamra, MD

4014448570

Outcome results