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

NCT04404894 | Active Not Recruiting

• 1 other identifier: URO-013
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Active Surveillance; Active Surveillance Durability; Prostate Cancer Treatment Selection; Prostate Cancer Risk Stratification; Prostate Cancer Oncological Outcomes

Outcome Measures

Primary Outcomes (1)

• Active Surveillance (AS) selection versus Definitive Therapy (DT

  The primary endpoint of the registry is Active Surveillance selection, defined as the proportion of all men who select Active Surveillance in lieu of definitive therapy following confirmatory diagnosis of localized Prostate Cancer and Prolaris testing. Active Surveillance selection is documented by the treating provider and reflects the patient-provider decision at the time to pursue Active Surveillance with no curative intent.

  1 Year

Secondary Outcomes (1)

• Active Surveillance Durability; Comorbidities

  Active Surveillance durability, date of diagnostic biopsy will be recorded as the Active Surveillance initiation date. Definitive treatments collected at baseline and annually up to 10 years Comorbidities collected annually up to 10 years.

Other Outcomes (4)

• Disease Progression

  Baseline to year 10

• Disease reclassification

  Baseline to year 10

• Baseline Clinicopathologic measures

  Baseline to year 10

Study Arms (1)

Prolaris tested patients with Prostate Cancer

Recently diagnosed patients with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites who have undergone Prolaris testing.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Urology Practices

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.

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead

Study Sites (7)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Manatee Medical Research Institute

Bradenton, Florida, 34205, United States

Location

UroPartners, LLC

Westchester, Illinois, 60440, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

The Urology Group

Memphis, Tennessee, 38018, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Walter Rayford, M.D.

  The Urology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: April 30, 2020
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)