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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.

Erica Akins

Thaylon Davis

Mina Behdad

Greg Gin, MD

Amy Boucher

Alan Miller, MD

Celeste Ruiz

Paul Yonover, MD

Brandy Yeater

Arthur Burnett, MD

Tracy Stewart

Walter Rayford, MD

Pamela Steele, BSN

Kelvin Moses, M.D., PhD

Walter Rayford, M.D.

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.

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.

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

Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing

• 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, 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, 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.

(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.

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, 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).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing	NCT04404894	Prostate Cancer		18 Years -	Myriad Genetic Laboratories, Inc.
Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing	NCT04404894	Prostate Cancer		18 Years -	Myriad Genetic Laboratories, Inc.

Spots Global Cancer Trial Database for prostate cancer risk stratification