ExosomeDx in MRI-negative Men With High PSA

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06966089
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-08
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 425

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity	duration 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
Specificity	duration 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

Secondary Outcome Measures

Name	Time	Method
Cancer Detection Rate	duration of study, average 3 months	Cancer Detection Rate (CDR): Cancer detection rate is defined as the proportion of enrolled patients with histologically Gleason grade group 1+ cancers and as determined by the Investigator.; Cancer detection rate = true positive (histologically Gleason grade 1+) / all tests performed
csPCa Detection Rate	duration of study, average 3 months	csPCa Detection Rate (csCDR): clinically significant cancer detection rate is defined as the proportion of enrolled patients with histologically Gleason grade group 2+ cancers.; csPCa detection rate = true positive (histologically Gleason grade 2+) / all tests performed
Biopsy aversion rate	duration of study, average 3 months	Biopsy aversion rate is defined as the proportion of patients in whom the biopsy could have been potentially averted using ExosomeDx, as compared to decisions based on PSA density.
Net Benefit	duration of study, average 3 months	Decision curve analysis will be used to calculate the net benefit of adding ExoDx to PSA density (including kinetics and density) and MRI in the diagnostic workflow following.; Net benefit is calculated across a range of threshold probabilities, defined as the minimum probability of disease at which further intervention would be warranted, as net benefit = sensitivity × prevalence - (1 - specificity) × (1 - prevalence) × w where w is the odds at the threshold probability.
Diagnostic Accuracy	duration of study, average 3 months	Accuracy is defined as the potential of ExoDx to correctly detect the presences or absence of disease.; Diagnostic Accuracy = (True Positive) + True Negative / All) \* 100
Positive Predictive Value (PPV)	duration of study, average 3 months	Positive predictive value is defined as the probability that an elevated ExoDx actually has cancer.; Positive Predictive Value = (True Positive)/(True Positive + False Positive)
Negative Predictive Value (NPV)	duration of study, average 3 months	Negative predictive value is defined as the probability a negative ExoDx test does not cancer.; Negative Predictive Value = (True Negative)/(True Negative + False Negative)

Trial Locations

Locations (6)

Mount Sinai Beth Israel / Union Square; 🇺🇸 New York, New York, United States

Mount Sinai West; 🇺🇸 New York, New York, United States

Mount Sinai Morningside; 🇺🇸 New York, New York, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Mount Sinai Queens; 🇺🇸 New York, New York, United States

Mount Sinai Brooklyn; 🇺🇸 New York, New York, United States