Prospective Validation of Prostate Biomarkers for Repeat Biopsy

NCT ID: NCT03082274

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2019-12-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ConfirmMDx

Intervention Type: 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.

SelectMDx

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

MDx Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MDxHealth

Irvine, California, United States

Countries

United States

Other Identifiers

PRIORITY

Identifier Type: -

Identifier Source: org_study_id