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ExoDx Test for Men with High PSA and Negative MRI

This study is looking at a new urine test called ExoDx to help decide if men with high PSA (Prostate-specific antigen, a blood test that can indicate prostate problems) and a negative MRI (Magnetic Resonance Imaging, a type of scan) still need a prostate biopsy. Currently, MRI helps decide who needs a biopsy, but it can miss some cancers. The ExoDx test analyzes specific genes in your urine to predict the presence of prostate cancer. Researchers want to see how well the ExoDx test (urinary ExoDx test) works at identifying prostate cancer compared to standard prostate biopsies (transrectal ultrasound-guided prostate biopsy or transperineal 12-core prostate biopsy). You might be able to join if you are a man aged 18 or older with a PSA between 2.0 and 10.0 ng/mL. The study aims to enroll 425 participants.

Study design
This is an interventional study, meaning participants will receive specific tests. It plans to enroll 425 men.
What's involved
You would provide a urine sample for the ExoDx test, and then undergo a prostate biopsy as part of standard medical practice.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes like sensitivity and specificity for an average of 3 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06966089

ExosomeDx in MRI-negative Men With High PSA

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
Icahn School of Medicine at Mount Sinai
~425 participants
Updated 2025-05-11 on ClinicalTrials.gov
What's tested:Urinary ExoDx testTransrectal ultrasound-guided prostate biopsyTransperineal 12-core prostate biopsy

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over duration of study, average 3 months
+1 more outcome measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

6 sites across 1 states
New York6

Study leadership

  • Nikhil Waingankar, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Nikhil Waingankar, MD
[email protected]
(718) 808-7777
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Sensitivityduration of study, average 3 months

    Sensitivity is defined as the probability that clinically significant cancer is detected when it is cancer. Sensitivity = true positive cases / true positive cases + false negative cases

  • Specificityduration of study, average 3 months

    Specificity is defined as the probability that clinically significant cancer is not detected when it is not cancer. Specificity = true negative cases / true negative cases + false positive cases