Prospective Validation of Prostate Biomarkers for Repeat Biopsy

NCT03082274 | Unknown

• 1 other identifier: PRIORITY
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison between clinical and pathological outcomes

  1 year

Study Arms (1)

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; Diagnostic Test: SelectMDx

Interventions

ConfirmMDx DIAGNOSTIC_TEST

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.

Men age 40-85 years with an initial negative prostate biopsy

SelectMDx DIAGNOSTIC_TEST

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.

Men age 40-85 years with an initial negative prostate biopsy

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• MDx Health: lead

Study Sites (1)

MDxHealth

Irvine, California, 92618, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma from each subject will be collected and stored for up to 10 years for future research.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 17, 2017
• Study Start: March 31, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)