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

NCT ID: NCT03511235

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 774 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2018-07-31

Brief 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.

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryan M Dechairo, PhD

Role: STUDY_DIRECTOR

Myriad Genetics, Inc.

Locations

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

Countries

United States

Other Identifiers

URO-009

Identifier Type: -

Identifier Source: org_study_id