ExosomeDx in MRI-negative Men With High PSA

NANot yet recruitingINTERVENTIONAL
Enrollment

425

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Prostate Cancer
Interventions
DEVICE

Urinary ExoDx test

A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.

DIAGNOSTIC_TEST

Transrectal ultrasound-guided prostate biopsy

Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.

DIAGNOSTIC_TEST

Transperineal 12-core prostate biopsy

Participants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test.

Trial Locations (6)

10003

Mount Sinai Beth Israel / Union Square, New York

10019

Mount Sinai West, New York

10025

Mount Sinai Morningside, New York

10029

Mount Sinai Hospital, New York

11102

Mount Sinai Queens, New York

11234

Mount Sinai Brooklyn, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bio-Techne Corporation

UNKNOWN

lead

Icahn School of Medicine at Mount Sinai

OTHER