Clinical trial NCT04404894: Long-Term Prospective Registry in Prostate Cancer Patients From Diverse Urology Practice Settings Following Prolaris® Testing
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Active Surveillance
Active Surveillance Durability
Prostate Cancer Treatment Selection
Prostate Cancer Risk Stratification
Prostate Cancer Oncological Outcomes
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology Practices

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Active Surveillance (AS) selection versus Definitive Therapy (DT
timeFrame: 1 Year
Secondary outcomes:
measure: Active Surveillance Durability; Comorbidities
timeFrame: 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.
Other outcomes:
measure: Disease Progression
timeFrame: Baseline to year 10
measure: Disease reclassification
timeFrame: Baseline to year 10
measure: Baseline Clinicopathologic measures
timeFrame: Baseline to year 10
measure: The Proportion of Men with PrCa who:
timeFrame: Baseline to year 10
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Bradenton
country: United States
facility: Manatee Medical Research Institute
state: Florida
city: Westchester
country: United States
facility: UroPartners, LLC
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Memphis
country: United States
facility: The Urology Group
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: The Urology Group
name: Walter Rayford, M.D.
role: PRINCIPAL_INVESTIGATOR
References: