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NCT03511235 · ClinicalTrials.gov registry record

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

A clinical trial of Prostate Cancer, sponsored by Myriad Genetic Laboratories.

Completed
Registry status
774
Enrollment target
8
Study locations

NCT03511235: Completed study of Prostate Cancer, sponsored by Myriad Genetic Laboratories.

NCT03511235 is a study of Prostate Cancer that has completed, run by Myriad Genetic Laboratories. The registered enrollment target is 774 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (28% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03511235, a study of Prostate Cancer, has completed, sponsored by Myriad Genetic Laboratories.

COMPLETED
Registry status
774 participants
Enrollment target
8
Study locations

Study Summary

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.

Conditions Studied

Study Locations (8)

California

  • Pacific Urology - Concord
  • Kar Urology - Orange
  • Golden Gate Urology - San Francisco

Arkansas

  • Arkansas Urology - Little Rock

Colorado

  • Urological Associates - Colorado Springs

Michigan

  • University of Michigan Urology Cancer Center - Ann Arbor

Missouri

  • Dr. Jeffrey Glaser, Urologist - Lake Saint Louis

New York

  • Memorial Sloane Kettering Cancer Center - New York

Trial Details

FieldValue
Enrollment Target 774 participants
Start Date 2018-03-12
Est. Completion 2018-07-31

Sponsor

Myriad Genetic Laboratories

15 total trials

What the Registry Record Tells You About NCT03511235

The ClinicalTrials.gov registry entry for NCT03511235 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 774 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (28% higher). The listed sponsor is Myriad Genetic Laboratories, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 0 interventions.

NCT03511235 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, Arkansas, Colorado.

Frequently Asked Questions

What is clinical trial NCT03511235 about?

NCT03511235 is a clinical study titled "Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing". 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...

What is the current status of trial NCT03511235?

This trial is currently completed. The enrollment target is 774 participants. The study started on 2018-03-12. Estimated completion is 2018-07-31.

What conditions does trial NCT03511235 study?

This clinical trial studies the following conditions: Prostate Cancer.

Who is sponsoring clinical trial NCT03511235?

This trial is sponsored by Myriad Genetic Laboratories, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03511235 being conducted?

This trial has 8 study locations across Arkansas, California, Colorado, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.