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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Active Surveillance (AS) selection versus Definitive Therapy (DT | 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. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Active Surveillance Durability; Comorbidities | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression | • Disease progression, measured as the proportion of men who:
|
Inclusion Criteria:
Exclusion Criteria:
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Urology Practices
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| Name | Affiliation | Role |
|---|---|---|
| Walter Rayford, M.D. | The Urology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| VA Long Beach Healthcare System |
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| 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. |
| Baseline to year 10 |
| Disease reclassification | 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 to year 10 |
| Baseline Clinicopathologic measures | 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. | Baseline to year 10 |
| The Proportion of Men with PrCa who: | (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. | Baseline to year 10 |
| Long Beach |
| California |
| 90822 |
| United States |
| Manatee Medical Research Institute | Bradenton | Florida | 34205 | United States |
| UroPartners, LLC | Westchester | Illinois | 60440 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| The Urology Group | Memphis | Tennessee | 38018 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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