ExosomeDx in MRI-negative Men With High PSA

NCT06966089 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY-24-00010
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  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

  duration of study, average 3 months

• Specificity

  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

  duration of study, average 3 months

Secondary Outcomes (7)

• Cancer Detection Rate

  duration of study, average 3 months

• csPCa Detection Rate

  duration of study, average 3 months

• Biopsy aversion rate

  duration of study, average 3 months

• Net Benefit

  duration of study, average 3 months

• Diagnostic Accuracy

  duration of study, average 3 months

Study Arms (1)

Participants with elevated or rising PSA

EXPERIMENTAL

Participants who have been diagnosed with an elevated or rising PSA as determined by their urologist, and who have a negative (PIRADS 1 or 2) prostate MRI will be offered enrollment in this trial. ExoDx Study Kit will be collected onsite. Participants will then be scheduled for transrectal ultrasound-guided or transperineal 12-core prostate biopsy as per the standard diagnostic practice.

Device: Urinary ExoDx test; Diagnostic Test: Transrectal ultrasound-guided prostate biopsy; Diagnostic Test: Transperineal 12-core prostate biopsy

Interventions

Urinary ExoDx test DEVICE

A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.

Participants with elevated or rising PSA

Transrectal ultrasound-guided prostate biopsy DIAGNOSTIC_TEST

Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.

Participants with elevated or rising PSA

Transperineal 12-core prostate biopsy DIAGNOSTIC_TEST

Participants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test.

Participants with elevated or rising PSA

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All men who present to Mount Sinai Health System urology clinic and, in the course of routine PSA screening, who are found to have an elevated PSA and a negative MRI (PIRADS 1 or 2) will be approached for consideration to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age for average risk
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Bio-Techne Corporation: collaborator

Study Sites (6)

Mount Sinai Beth Israel / Union Square

New York, New York, 10003, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Mount Sinai Morningside

New York, New York, 10025, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Mount Sinai Queens

New York, New York, 11102, United States

Location

Mount Sinai Brooklyn

New York, New York, 11234, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Nikhil Waingankar, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikhil Waingankar, MD

CONTACT

(718) 808-7777; nikhil.waingankar@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism Email proposal to Principal Investigator.

Locations

US (6)