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

Running, not enrolling

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT04404894

Run by

Myriad Genetic Laboratories, Inc.

People needed

500

Starts

2020-04-30

Expected to finish

2029-11-01

Last updated by the study team

2025-07-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 years or older on date of enrollment.
• Diagnosed within the past six months with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites.
• Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample as standard of care.
• Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

You may not qualify if…

• 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 decision making during Active Surveillance.
• Currently participating in an interventional clinical trial.
• Unable to provide routine clinical informed consent.

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Manatee Medical Research Institute — Bradenton, Florida, United States
• UroPartners, LLC — Westchester, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• The Urology Group — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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