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Completed No phase listed Observational

Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing

ClinicalTrials.gov ID: NCT03511235

Public ClinicalTrials.gov record NCT03511235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 12:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Medicare is requesting outcome data on patients who received Prolaris testing and were prescribed active surveillance (AS). In order to ensure appropriate patient care, it is important to understand how this added prognostic information influences the selection and durability of AS and corresponding clinical outcomes. To address this knowledge gap, this study will evaluate how frequently men with low disease-specific mortality (DSM) risk based on Prolaris CCR score and who meet NCCN low-risk criteria initially select AS (AS selection). This study also will assess how long Prolaris-tested men who initially select AS remain on this course before proceeding to definitive treatment (AS durability), and whether AS duration impacts biochemical recurrence (BCR) and metastasis risk in these men. This retrospective, observational and multi-site study will combine patient CCR scores with longitudinal clinical data to address these questions.

Study identification

NCT ID
NCT03511235
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
774 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
Up to 80 Years
Sex
Male
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 11, 2018
Primary completion
Jul 30, 2018
Completion
Jul 30, 2018
Last update posted
Oct 5, 2020

2018

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
8
Facility City State ZIP Site status
Arkansas Urology Little Rock Arkansas 72211
Pacific Urology Concord California 94520
Kar Urology Orange California 92868
Golden Gate Urology San Francisco California 94114
Urological Associates Colorado Springs Colorado 80907
University of Michigan Urology Cancer Center Ann Arbor Michigan 48109
Dr. Jeffrey Glaser, Urologist Lake Saint Louis Missouri 63367
Memorial Sloane Kettering Cancer Center New York New York 10065

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03511235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 5, 2020 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03511235 live on ClinicalTrials.gov.

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