NCT03082274

Prospective Validation of Prostate Biomarkers for Repeat Biopsy

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: MDx Health · Industry
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-31
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2017-03-17
• Last updated: 2018-08-17

Locations

1 site across 1 country: United States