Clinical Outcomes in Men With Prostate Cancer Who Selected Active Surveillance Using Prolaris® Testing (URO-009Low)

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 Overview

• Status: Completed
• Conditions: Prostate Cancer

Detailed Description

This is a multicenter, retrospective, observational study in men diagnosed with localized PrCa who had Prolaris testing prior to the treatment decision. The study will collect demographic, clinical, pathologic, and Prolaris test data from medical records and Myriad's Prolaris database.

The primary objective of this study is to evaluate the rate of BCR or metastasis, whichever occurs first, among Prolaris-tested men who were at low risk of DSM (≤3.2%), who also met NCCN low-risk criteria, and who were initially treated with AS.

The secondary objectives of the study are to evaluate the frequency of AS selection among all men who had low DSM risk, as determined by Prolaris testing and AS durability among Prolaris-tested men with low DSM risk who selected and initiated this treatment.

• Study Type: Observational
• Enrollment (Actual): 774

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Urology
  • California
    • Concord, California, United States, 94520
      • Pacific Urology
    • Orange, California, United States, 92868
      • Kar Urology
    • San Francisco, California, United States, 94114
      • Golden Gate Urology
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Urological Associates
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Urology Cancer Center
  • Missouri
    • Lake Saint Louis, Missouri, United States, 63367
      • Dr. Jeffrey Glaser, Urologist
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloane Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Prolaris-tested men diagnosed with low-risk prostate cancer.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of BCR or metastasis after selection of active surveillance (AS)	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.	Up to five years post Prolaris report

Collaborators and Investigators

• Sponsor: Myriad Genetic Laboratories, Inc.
• Investigators: Study Director: Bryan M Dechairo, PhD, Myriad Genetics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 2, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: URO-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No