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

NCT03511235 | Completed

• 1 other identifier: URO-009
• Study Type: observational
• Target: 774
• Locations: 1 country
• Sites: 8

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 80 Years
• Gender Eligibility Details: Not based on self-representation of gender identity
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead

Study Sites (8)

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Pacific Urology

Concord, California, 94520, United States

Location

Kar Urology

Orange, California, 92868, United States

Location

Golden Gate Urology

San Francisco, California, 94114, United States

Location

Urological Associates

Colorado Springs, Colorado, 80907, United States

Location

University of Michigan Urology Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Dr. Jeffrey Glaser, Urologist

Lake Saint Louis, Missouri, 63367, United States

Location

Memorial Sloane Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bryan M Dechairo, PhD

  Myriad Genetics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: March 12, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

US (8)