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

Completed

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03511235

Run by

Myriad Genetic Laboratories, Inc.

People needed

774

Starts

2018-03-12

Expected to finish

2018-07-31

Last updated by the study team

2020-10-06

Who can join

Age: any, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with localized PrCa at participating sites between January 1, 2013 and August 1, 2017.
• Have undergone Prolaris testing and have a CCR score with estimated DSM risk ≤3.2%.
• Have NCCN low-risk disease2.

You may not qualify if…

• Received any therapy other than 5α-reductase inhibitor (5-ARI) prior to diagnostic biopsy.
• Over 80 years of age at diagnosis.
• History of hypogonadism at the time of diagnosis.
• Co-occurring malignancy, excluding non-melanoma skin cancer.
• Enrolled in another investigational study.

Where it is running

• Arkansas Urology — Little Rock, Arkansas, United States
• Pacific Urology — Concord, California, United States
• Kar Urology — Orange, California, United States
• Golden Gate Urology — San Francisco, California, United States
• Urological Associates — Colorado Springs, Colorado, United States
• University of Michigan Urology Cancer Center — Ann Arbor, Michigan, United States
• Dr. Jeffrey Glaser, Urologist — Lake Saint Louis, Missouri, United States
• Memorial Sloane Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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