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

• ClinicalTrials.gov Identifier: NCT04404894
• Recruitment Status: Recruiting
• First Posted: May 28, 2020
• Last Update Posted: May 11, 2022
• Sponsor: Myriad Genetic Laboratories, Inc.
• Information provided by (Responsible Party): Myriad Genetic Laboratories, Inc.

Study Description

Brief Summary:

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.

Condition or disease
Prostate Cancer

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Years
• Official Title: Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
• Actual Study Start Date: April 30, 2020
• Estimated Primary Completion Date: November 2029
• Estimated Study Completion Date: November 2029

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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).

Other Outcome Measures:

1. Disease Progression [ Time Frame: Baseline to year 10 ]

   • Disease progression, measured as the proportion of men who:

   • Initiate and remain on Active Surveillance and subsequently experience distant metastasis or disease-specific mortality.
   • Initiate Active Surveillance and proceed to definitive therapy, or initially select definitive therapy, and subsequently experience biochemical recurrence (BCR), distant metastasis or disease-specific mortality. For radical prostatectomy (RP) patients, BCR is defined as PSA >0.2 ng/mL on at least two occasions more than two weeks apart or initiation of any salvage therapy greater than or equal to 6 months after surgery. For patients treated by external beam radiation therapy (EBRT), BCR is defined by reaching a post-EBRT PSA of nadir + 2 ng/mL (Phoenix criteria) or initiation of any salvage therapy 6 months after radiation.
2. Disease reclassification [ Time Frame: Baseline to year 10 ]
   Disease reclassification, defined as a patient initially treated with Active Surveillance for whom follow-up biopsy results in reclassification of the disease into a different NCCN risk category.
3. Baseline Clinicopathologic measures [ Time Frame: Baseline to year 10 ]
   Baseline clinicopathologic measures, including pre-biopsy PSA, date of biopsy, prostate volume, biopsy findings, total number of biopsy cores, number of positive cores, clinical stage, Gleason score, NCCN risk category, and Prostate Magnetic Resonance Imaging (MRI) assessment results with Prostate Imaging Reporting and Data System (PI-RADS) score(s) when available.
4. The Proportion of Men with PrCa who: [ Time Frame: Baseline to year 10 ]
   (1) Meet NCCN hereditary high-risk criteria, (2) undergo and complete hereditary cancer genetic testing; and (3) are found to carry pathogenic variants in tested cancer-predisposition genes.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Urology Practices

Criteria

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.

Contacts and Locations

Contacts

Contact: Erica Akins; 513-477-7732; Erica.Akins@myriad.com

Contact: Thaylon Davis; 801-505-5109; Tdavis@myriad.com

Locations

United States, California

VA Long Beach Healthcare System; Recruiting

Long Beach, California, United States, 90822

Contact: Mina Behdad 562-826-8000 ext 5062 mina.behdad@va.gov

Principal Investigator: Greg Gin, MD

United States, Florida

Manatee Medical Research Institute; Recruiting

Bradenton, Florida, United States, 34205

Contact: Amy Boucher 941-792-0340 ext 1328 aboucher@mmrinstitute.com

Principal Investigator: Alan Miller, MD

University of Florida - Jacksonville; Withdrawn

Jacksonville, Florida, United States, 32209

United States, Georgia

Georgia Urology; Withdrawn

Decatur, Georgia, United States, 30033

United States, Illinois

UroPartners, LLC; Recruiting

Westchester, Illinois, United States, 60440

Contact: Celeste Ruiz 708-273-3735 CRuiz@uropartners.com

Principal Investigator: Paul Yonover, MD

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21218

Contact: Brandy Yeater dyeater1@jhmi.edu

Principal Investigator: Arthur Burnett, MD

United States, Tennessee

The Urology Group; Recruiting

Memphis, Tennessee, United States, 38018

Contact: Tracy Stewart 901-832-9909 tstewart@memphisurology.com

Principal Investigator: Walter Rayford, MD

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Contact: Pamela Steele, BSN 635-343-2120 pamela.steele@vumc.org

Principal Investigator: Kelvin Moses, M.D., PhD

Sponsors and Collaborators

Myriad Genetic Laboratories, Inc.

Investigators

• Principal Investigator: Walter Rayford, M.D.; The Urology Group

More Information

• Responsible Party: Myriad Genetic Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT04404894
• Other Study ID Numbers: URO-013
• First Posted: May 28, 2020
• Last Update Posted: May 11, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Myriad Genetic Laboratories, Inc.:

Prostate Cancer; Active Surveillance; Active Surveillance Durability; Prostate Cancer Treatment Selection; Prostate Cancer Risk Stratification; Prostate Cancer Oncological Outcomes

Additional relevant MeSH terms:

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