Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing

Overview

This registry will evaluate treatment selection for patients with newly diagnosed, localized prostate cancer following Prolaris testing. It will measure the proportion of men who initially select treatment with active surveillance, the time frame between active surveillance selection and any change in treatment, and clinical outcomes.

Full Title of Study: “Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris┬« Testing”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2021

Detailed Description

To evaluate use of the Prolaris score in treatment management decisions in an ethnically and racially diverse population of men who have been newly diagnosed with prostate cancer and who are potential candidates for active surveillance. This registry will evaluate oncologic and co-morbidity outcomes in patients who receive Prolaris testing. Additionally, the registry will measure the prevalence and distribution of pathogenic mutations in hereditary cancer risk-associated genes among men with prostate cancer who meet National Cancer Center Network (NCCN) criteria for hereditary cancer genetic testing.

The primary objective of this registry is to evaluate initial selection of active surveillance (Active Surveillance selection) versus definitive therapy (DT) among men with newly diagnosed prostate cancer who make treatment decisions with Prolaris testing, and among patient subsets defined by race/ethnicity.

The secondary objectives of the registry are to evaluate progression of from Active Surveillance to definitive therapy over time and prostate cancer-associated morbidities that affect quality of life among men with newly diagnosed prostate cancer and who undergo Prolaris testing, and among patient subsets defined by racial/ethnic background and ancestry.

Arms, Groups and Cohorts

  • Prolaris tested patients with Prostate Cancer
    • Recently diagnosed patients with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites who have undergone Prolaris testing.

Clinical Trial Outcome Measures

Primary Measures

  • Active Surveillance (AS) selection versus Definitive Therapy (DT
    • Time Frame: 1 Year
    • The primary endpoint of the registry is Active Surveillance selection, defined as the proportion of all men who select Active Surveillance in lieu of definitive therapy following confirmatory diagnosis of localized Prostate Cancer and Prolaris testing. Active Surveillance selection is documented by the treating provider and reflects the patient-provider decision at the time to pursue Active Surveillance with no curative intent.

Secondary Measures

  • Active Surveillance Durability; Comorbidities
    • Time Frame: Active Surveillance durability, date of diagnostic biopsy will be recorded as the Active Surveillance initiation date. Definitive treatments collected at baseline and annually up to 10 years Comorbidities collected annually up to 10 years.
    • Active Surveillance durability, measured as the length of time between the Active Surveillance initiation date and the first definitive therapy date. Comorbidities, including voiding problems, erectile dysfunction, bowel dysfunction, stress or urgency incontinence, depression, and anxiety, as measured by validated, standard of care quality-of-life assessments: the Expanded Prostate Cancer Index Composite Instrument (EPIC-26) and the Generalized Anxiety Disorder scale (GAD-7).

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 years or older on date of enrollment.
  • Diagnosed within the past six months with histologically proven, localized adenocarcinoma of prostate determined via transrectal ultrasonography and biopsy of at least 10 prostate sites.
  • Received Prolaris testing and a resulting CCR score from the diagnostic biopsy sample as standard of care.
  • Can be monitored for disease progression according to standard of care (e.g., current NCCN guidelines).

Exclusion Criteria

  • Estimated life expectancy < 10 years.
  • Clinical evidence of metastasis or lymph node involvement.
  • Received pelvic radiation prior to biopsy.
  • Received androgen deprivation therapy (ADT) prior to biopsy; however, 5 alpha reductase inhibitor (5-ARI) use is permitted.
  • Plan to use PrCa-specific prognostic testing other than PSA for treatment decision making during Active Surveillance.
  • Currently participating in an interventional clinical trial.
  • Unable to provide routine clinical informed consent.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Myriad Genetic Laboratories, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walter Rayford, M.D., Principal Investigator, The Urology Group
  • Overall Contact(s)
    • Erica Akins, 513-477-7732, Erica.Akins@myriad.com

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