NCT06966089Not yet recruiting
ExosomeDx in MRI-negative Men With High PSA
Evaluation of Urinary Exosomes as a Risk Stratification Tool Among Men With Elevated PSAs and Negative Prostate MRIs
Source: ClinicalTrials.gov · Last updated 11 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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, which is invasive and carries a 3-5% risk of serious infection. Recent data shows the negative predictive value of MRI to be only 77%, indicating that some men may inappropriately forego biopsy based on a negative MRI. Urinary exosomes can be captured and analyzed by the ExosomeDx (ExoDx) Prostate test, a urine based, gene signature derived from PCA3 (prostate cancer antigen 3) and ERG (erythroblast transformation-specific related gene), and SPDEF (SAM pointed domain-containing ETS transcription factor); ExoDx carries a 90% negative predictive value. The use of ExoDx test among patients with negative MRIs has the potential to improve the risk stratification of patients with an elevated PSA in a way that the Urologist can more accurately determine which patients need to undergo prostate biopsy. In doing so, the Urologist can better risk-stratify which patients should undergo prostate biopsy and be exposed to the associated potential risks, and also be more confident about the safety of foregoing biopsy in those patients with negative MRI and negative ExoDx test.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 425 (estimated)
- First submitted
- 2 May 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Prostate cancer
- NCT number
- NCT06966089
What you commit to
- Study type: Interventional
- Planned participants: 425
- From 1 Aug 2025 to the primary completion date, 31 Aug 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current histologic or pathologic confirmed diagnosis of prostate cancer
- Prior transrectal ultrasound within the last 5 years
Other illness
- Any prior cancer diagnosis within the last 5 years
- 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)
Other
- An individual who meets any of the following criteria will be excluded from participation in this study;
- On immunosuppression or predefined immunosuppressed state
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Morningside Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Brooklyn Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai West Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Beth Israel / Union Square Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mount Sinai Queens Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.