ExosomeDx in MRI-negative Men With High PSA

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new urine test called ExosomeDx (ExoDx) to see if it can help men with high levels of prostate-specific antigen (PSA) who have had negative MRI results. Currently, doctors use MRI scans to decide if patients need a prostate biopsy, which is a procedure that carries some risks. However, MRIs sometimes miss detecting prostate cancer, leading to some men not getting the biopsies they might need. The ExoDx test analyzes specific gene markers in urine and has shown a high accuracy in ruling out prostate cancer, which could help doctors better determine who really needs a biopsy.

To participate in this trial, men aged 18 and older who have a PSA level between 2.0 and 10.0 ng/mL and a negative MRI result (with a PIRADS score of 1 or 2) may be eligible. Participants must be willing to provide consent and undergo a prostate biopsy if needed. Throughout the trial, participants can expect close monitoring and support from the research team as they explore whether the ExoDx test can improve the decision-making process regarding prostate biopsies. It's important to note that men with a history of prostate cancer or certain health conditions may not be eligible for this study.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • To be eligible to participate in this study, an individual must meet all the following criteria;
• • Willingness to participate and provide signed and dated informed consent form
• • Male (sex)
• • Age ≥ 18 years
• • PSA screen-eligible, per investigator discretion
• • 45-75 years of age for average risk
• • 40-75 years of age for high risk
• • PSA ≥ 2.0 ng/mL and ≤ 10.0 ng/mL
• • MRI PIRADS score of 1 or 2
• • ECOG 0-1
• • Must have a negative urine culture prior to biopsy
• • No prior prostate biopsies within the last 5 years (biopsy-naïve)
• • Willingness to undergo a prostate biopsy as part of the diagnostic work-up
• • Digital rectal exam with no palpable nodules
• Exclusion Criteria:
• • An individual who meets any of the following criteria will be excluded from participation in this study;
• • Prior or current histologic or pathologic confirmed diagnosis of prostate cancer
• • Prior transrectal ultrasound within the last 5 years
• • Any prior cancer diagnosis within the last 5 years
• • On immunosuppression or predefined immunosuppressed state
• • A known coagulopathy predisposition to bleeding
• • Diagnoses of any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• • Cognitive inability or psychiatric conditions that preclude informed decision making or compliance with study requirements (per investigator discretion)