Clinical trial NCT06966089: ExosomeDx in MRI-negative Men With High PSA
Official title: Evaluation of Urinary Exosomes as a Risk Stratification Tool Among Men With Elevated PSAs and Negative Prostate MRIs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Urinary Exosome
ExoDx Prostate test
ExosomeDx
ERG
Erythroblast Transformation-Specific Related Gene
SPDEF
SAM Pointed Domain-containing ETS Transcription Factor
Exosome Diagnostic Intelligence
EPI
Prostate cancer
Prostate Biopsy
Exosome
Prostate MRI
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Bio-Techne Corporation
First posted: 2025-05-11
Enrollment: 425
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective diagnostic test design will be used to compare the sensitivity of ExoDx with PSA density (H0: SensitivityPSA Density ≤ SensitivityExoDx versus H1: SensitivityPSA Density \> SensitivityExoDx) and the specificity (H0: Specificity PSA Density ≤ Specificity ExoDxversus H1: Specificity PSA Density \> Specificity ExoDx).
Primary purpose: DIAGNOSTIC

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, 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.


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)

Primary outcomes:
measure: Sensitivity
timeFrame: duration of study, average 3 months
measure: Specificity
timeFrame: duration of study, average 3 months
Secondary outcomes:
measure: Cancer Detection Rate
timeFrame: duration of study, average 3 months
measure: csPCa Detection Rate
timeFrame: duration of study, average 3 months
measure: Biopsy aversion rate
timeFrame: duration of study, average 3 months
measure: Net Benefit
timeFrame: duration of study, average 3 months
measure: Diagnostic Accuracy
timeFrame: duration of study, average 3 months
measure: Positive Predictive Value (PPV)
timeFrame: duration of study, average 3 months
measure: Negative Predictive Value (NPV)
timeFrame: duration of study, average 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel / Union Square
state: New York
city: New York
country: United States
facility: Mount Sinai West
state: New York
city: New York
country: United States
facility: Mount Sinai Morningside
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Queens
state: New York
city: New York
country: United States
facility: Mount Sinai Brooklyn
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Nikhil Waingankar, MD
role: PRINCIPAL_INVESTIGATOR
References: