Prospective Validation of Prostate Biomarkers for Repeat Biopsy (PRIORITY)

Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study

Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy scheduled for repeat biopsy.

Subjects must have had their negative index prostate biopsy procedure within 30 months of being scheduled for their repeat biopsy.

All enrolled subjects will have all core tissues from the initial negative biopsy blinded and tested with the assay.

All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample collected immediately following DRE but in advance of the repeat biopsy; samples will be blinded and sent to MDxHealth for evaluation.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: ConfirmMDx; Diagnostic test: SelectMDx

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • MDxHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

ConfirmMDx assay will be utilized to blindly test the needle biopsy cores of the index negative prostate biopsy (all cores) of men about to undergo repeat prostate biopsy. It is postulated that the test may aid in improved patient risk stratification for repeat biopsy, discriminating patients with no cancer/low grade prostate cancer (GS6) who are at sufficiently low risk to avoid repeat biopsy, while also identifying patients at increased risk for clinical significant disease (≥ GS7) who may benefit from early intervention.

In this current study, SelectMDx will be used to blindly test urine samples obtained preceding a repeat prostate biopsy to validate the test's ability to predict risk for high-grade disease. The intent is to demonstrate the test's ability to non-invasively stratify those patients at risk for aggressive disease, who require a repeat prostate biopsy, versus those at sufficiently low risk who may avoid unnecessary repeat biopsy.

Description

Inclusion Criteria:

• Males, aged 40 years to 85, who underwent a previous cancer-negative prostate biopsy within 30 months of being scheduled for a repeat biopsy.
• The initial TRUS guided negative prostate biopsy must have collected a minimum of 10 tissue cores and sections from all prostate biopsy cores collected by the physician must be submitted to MDxHealth in order to allow for full comprehensive testing/evaluation of all the sections of the patient's prostate prior to the scheduled repeat biopsy.
• Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue is available (40 microns preferable).
• Previous biopsy histology may include the presence of high-grade prostatic intraepithelial neoplasia (HGPIN), proliferative inflammatory atrophy (PIA), glandular inflammation, atypical small acinar proliferation (ASAP) or atypical cells.
• Tissue was extracted using standard TRUS guided biopsy core extraction (and not transurethral resection of the prostate (TURP).
• Pre-DRE serum sample, pre-DRE plasma sample, and Post-DRE urine sample to be collected in advance of the repeat biopsy. Samples can be collected within three months of the scheduled repeat biopsy, up until the day of, but prior to, the procedure.

Exclusion Criteria:

• Patient who has undergone previously testing by ConfirmMDx from the same biopsy
• Patients with prior diagnosis of prostate cancer in any previous biopsy.
• Patients with a limited life expectancy and generally not considered for a repeat Tissue extracted using transurethral resection of the prostate (TURP) procedures
• Patients with a history of cancer (except basal cell carcinoma)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Men age 40-85 years with an initial negative prostate biopsy; Men age 40 - 85 years of age Previous negative prostate biopsy within 30 months.

Diagnostic test: ConfirmMDx; ConfirmMDx is a molecular diagnostic assay which utilizes DNA isolated from biopsy tissues to determine if aberrant DNA methylation is occurring in three genes: GSTP1, RASSF1 and APC. ConfirmMDx is currently available to clinicians for use in cancer-negative extended-core biopsies to determine if occult cancer is present in the prostate.; Diagnostic test: SelectMDx; SelectMDx for Prostate Cancer is a reverse-transcription PCR (RT-PCR) assay performed on post-DRE, first-void urine specimens from patients with clinical risk factors for prostate cancer, who are being considered for biopsy. The test measures the mRNA levels of the DLX1 and HOXC6 biomarkers, using KLK3 as internal reference gene, to aid in patient selection for prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validate ConfirmMDx for Prostate Cancer to predict the outcome of repeat biopsy	The primary objectives of this prospective, multi-center study are twofold: Validate use of the ConfirmMDx for Prostate Cancer to predict the outcome of a repeat biopsy in men with a previous negative prostate biopsy using tissue.; Validate use of the SelectMDx for Prostate Cancer to predict the outcome of a repeat biopsy in men with a previous negative prostate biopsy using urine.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between clinical and pathological outcomes	Subset analyses conducted in appropriate groups, such as patients with available data from radical prostatectomy, and correlate this data with the ConfirmMDx and SelectMDx results.; Evaluate rate of cancer detection on repeat biopsy and associated complications.; Evaluate the findings of MRI fusion biopsy with standard 12 core TRUS guided biopsy (if available).	1 year

Collaborators and Investigators

• Sponsor: MDx Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2017
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): December 30, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 10, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PRIORITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No