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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.

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.

Information from the National Library of Medicine

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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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404894

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Contact: Erica Akins 513-477-7732 Erica.Akins@myriad.com
Contact: Thaylon Davis 801-505-5109 Tdavis@myriad.com

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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.
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Principal Investigator: Walter Rayford, M.D. The Urology Group
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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT04404894    
Other Study ID Numbers: URO-013
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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