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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404894
• Other study ID #: URO-013
• Status: Recruiting
• Start date: April 30, 2020
• Est. completion date: November 2029

Study information

• Verified date: July 2023
• Source: Myriad Genetic Laboratories, Inc.
• Contact: Erica Akins
• Phone: 513-477-7732
• Email: Erica.Akins[@]myriad.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2029
• Est. primary completion date: November 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Manatee Medical Research Institute	Bradenton	Florida
United States	Georgia Urology	Decatur	Georgia
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	VA Long Beach Healthcare System	Long Beach	California
United States	The Urology Group	Memphis	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	UroPartners, LLC	Westchester	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Myriad Genetic Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease Progression	• 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.	Baseline to year 10
Other	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
Other	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
Other	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
Primary	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
Secondary	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).	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.