Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing

Last updated: January 14, 2025
Sponsor: Myriad Genetic Laboratories, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT04404894
URO-013
  • Ages > 18
  • Male

Study Summary

This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older on date of enrollment.

  • Diagnosed within the past six months with histologically proven, localizedadenocarcinoma of prostate determined via transrectal ultrasonography and biopsy ofat least 10 prostate sites.

  • Received Prolaris testing and a resulting CCR score from the diagnostic biopsysample as standard of care.

  • Can be monitored for disease progression according to standard of care (e.g.,current NCCN guidelines).

Exclusion

Exclusion Criteria:

  • Estimated life expectancy < 10 years.

  • Clinical evidence of metastasis or lymph node involvement.

  • Received pelvic radiation prior to biopsy.

  • Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha-reductase inhibitor (5-ARI) use is permitted.

  • Plan to use PrCa-specific prognostic testing other than PSA for treatment decisionmaking during Active Surveillance.

  • Currently participating in an interventional clinical trial.

  • Unable to provide routine clinical informed consent.

Study Design

Total Participants: 500
Study Start date:
April 30, 2020
Estimated Completion Date:
November 30, 2029

Study Description

To evaluate use of the Prolaris score in treatment management decisions in an ethnically and racially diverse population of men who have been newly diagnosed with prostate cancer and who are potential candidates for active surveillance. This registry will evaluate oncologic and co-morbidity outcomes in patients who receive Prolaris testing. Additionally, the registry will measure the prevalence and distribution of pathogenic mutations in hereditary cancer risk-associated genes among men with prostate cancer who meet National Cancer Center Network (NCCN) criteria for hereditary cancer genetic testing.

The primary objective of this registry is to evaluate initial selection of active surveillance (Active Surveillance selection) versus definitive therapy (DT) among men with newly diagnosed prostate cancer who make treatment decisions with Prolaris testing, and among patient subsets defined by race/ethnicity.

The secondary objectives of the registry are to evaluate progression of from Active Surveillance to definitive therapy over time and prostate cancer-associated morbidities that affect quality of life among men with newly diagnosed prostate cancer and who undergo Prolaris testing, and among patient subsets defined by racial/ethnic background and ancestry.

Connect with a study center

  • Urology Centers of Alabama

    Homewood, Alabama 35209
    United States

    Site Not Available

  • VA Long Beach Healthcare System

    Long Beach, California 90822
    United States

    Site Not Available

  • Manatee Medical Research Institute

    Bradenton, Florida 34205
    United States

    Site Not Available

  • University of Florida - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Georgia Urology

    Decatur, Georgia 30033
    United States

    Site Not Available

  • UroPartners, LLC

    Westchester, Illinois 60440
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • The Urology Group

    Memphis, Tennessee 38018
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.