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
|Condition or disease|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|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|
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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Erica Akins||513-477-7732||Erica.Akins@myriad.com|
|Contact: Thaylon Davis||801-505-5109||Tdavis@myriad.com|
|United States, California|
|VA Long Beach Healthcare System||Recruiting|
|Long Beach, California, United States, 90822|
|Contact: Mina Behdad 562-826-8000 ext 5062 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Alan Miller, MD|
|University of Florida - Jacksonville||Withdrawn|
|Jacksonville, Florida, United States, 32209|
|United States, Georgia|
|Decatur, Georgia, United States, 30033|
|United States, Illinois|
|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 email@example.com|
|Principal Investigator: Arthur Burnett, MD|
|United States, Tennessee|
|The Urology Group||Recruiting|
|Memphis, Tennessee, United States, 38018|
|Contact: Tracy Stewart 901-832-9909 firstname.lastname@example.org|
|Principal Investigator: Walter Rayford, MD|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Pamela Steele, BSN 635-343-2120 email@example.com|
|Principal Investigator: Kelvin Moses, M.D., PhD|
|Principal Investigator:||Walter Rayford, M.D.||The Urology Group|