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

Myriad Genetic Laboratories

Status: Active, not recruiting

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT04404894

URO-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Prolaris tested patients with Prostate Cancer

Description:

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.