Status:
NOT_YET_RECRUITING
ExosomeDx in MRI-negative Men With High PSA
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Bio-Techne Corporation
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Magnetic resonance imaging (MRI) has become the current standard of care in risk stratifying men with an elevated Prostate-specific antigen (PSA) to determine who needs to undergo prostate biopsy, whi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT06966089
Start Date
August 1 2025
End Date
August 1 2026
Last Update
May 11 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Beth Israel / Union Square
New York, New York, United States, 10003
2
Mount Sinai West
New York, New York, United States, 10019
3
Mount Sinai Morningside
New York, New York, United States, 10025
4
Mount Sinai Hospital
New York, New York, United States, 10029