ExosomeDx in MRI-negative Men With High PSA

May 2, 2025 updated by: Nikhil Waingankar, Icahn School of Medicine at Mount Sinai

Evaluation of Urinary Exosomes as a Risk Stratification Tool Among Men With Elevated PSAs and Negative Prostate MRIs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
425

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10019
        • Mount Sinai West
        • Sub-Investigator:
          • Craig Nobert
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Nikhil Waigankar
      • New York, New York, United States, 10025
        • Mount Sinai Morningside
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel / Union Square
        • Sub-Investigator:
          • Michael Palese
      • New York, New York, United States, 11102
        • Mount Sinai Queens
        • Sub-Investigator:
          • Nikhil Waigankar
      • New York, New York, United States, 11234
        • Mount Sinai Brooklyn
        • Principal Investigator:
          • Nikhil Waigankar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Participants with elevated or rising PSA
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
A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
Diagnostic test: Transrectal ultrasound-guided prostate biopsy
Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.
Diagnostic test: Transperineal 12-core prostate biopsy
Participants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: 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
duration of study, average 3 months
Specificity
Time Frame: 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
duration of study, average 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cancer Detection Rate
Time Frame: 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
duration of study, average 3 months
csPCa Detection Rate
Time Frame: 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
duration of study, average 3 months
Biopsy aversion rate
Time Frame: 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.
duration of study, average 3 months
Net Benefit
Time Frame: 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.
duration of study, average 3 months
Diagnostic Accuracy
Time Frame: 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
duration of study, average 3 months
Positive Predictive Value (PPV)
Time Frame: 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)
duration of study, average 3 months
Negative Predictive Value (NPV)
Time Frame: 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)
duration of study, average 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bio-Techne Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nikhil Waingankar, MD, Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY-24-00010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism Email proposal to Principal Investigator.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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