Prostate CancerNCT06966089
ExosomeDx in MRI-negative Men With High PSA
A study testing Urinary ExoDx test, Transrectal ultrasound-guided prostate biopsy and Transperineal 12-core prostate biopsy in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Urinary ExoDx test, Transrectal ultrasound-guided prostate biopsy and Transperineal 12-core prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Mount Sinai Beth Israel / Union Square
New York, New York, 10003
Michael Palese
Mount Sinai West
New York, New York, 10019
Craig Nobert
Mount Sinai Morningside
New York, New York, 10025
Mount Sinai Hospital
New York, New York, 10029
Nikhil Waingankar, MD, 718-808-7777, nikhil.waingankar@mountsinai.org
Nikhil Waigankar
Mount Sinai Queens
New York, New York, 11102
Nikhil Waigankar
Mount Sinai Brooklyn
New York, New York, 11234
Nikhil Waigankar
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- Urinary ExoDx test, Transrectal ultrasound-guided prostate biopsy, Transperineal 12-core prostate biopsy
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary ExoDx testDevice
A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
Transrectal ultrasound-guided prostate biopsyDiagnostic test
Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.
Transperineal 12-core prostate biopsyDiagnostic test
Participants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Urinary ExoDx test; Diagnostic Test: Transrectal ultrasound-guided prostate biopsy; Diagnostic Test: Transperineal 12-core prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: duration of study, average 3 months
Secondary outcomes (7)
Cancer Detection Rate
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
Measured: duration of study, average 3 months
csPCa Detection Rate
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
Measured: duration of study, average 3 months
Biopsy aversion rate
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.
Measured: duration of study, average 3 months
Net Benefit
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.
Measured: duration of study, average 3 months
Diagnostic Accuracy
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
Measured: duration of study, average 3 months
Positive Predictive Value (PPV)
Positive predictive value is defined as the probability that an elevated ExoDx actually has cancer.
Positive Predictive Value = (True Positive)/(True Positive + False Positive)
Measured: duration of study, average 3 months
Negative Predictive Value (NPV)
Negative predictive value is defined as the probability a negative ExoDx test does not cancer.
Negative Predictive Value = (True Negative)/(True Negative + False Negative)
Measured: duration of study, average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Bio-Techne Corporation
- Responsible party
- Principal investigator, Nikhil Waingankar, Icahn School of Medicine at Mount Sinai
- Investigators
- Nikhil Waingankar, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966089
- Sponsor's protocol ID
- STUDY-24-00010
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Urinary Exosomes as a Risk Stratification Tool Among Men With Elevated PSAs and Negative Prostate MRIs
- ClinicalTrials.gov ID
- NCT06966089
- Acronym / sponsor ID
- STUDY-24-00010
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Bio-Techne Corporation
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Participants with elevated or rising PSA | Experimental | Device: Urinary ExoDx test, Diagnostic Test: Transrectal ultrasound-guided prostate biopsy, Diagnostic Test: Transperineal 12-core prostate biopsyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary ExoDx testA urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory. | Device | Participants with elevated or rising PSA |
| Transrectal ultrasound-guided prostate biopsyParticipants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test. | Diagnostic test | Participants with elevated or rising PSA |
| Transperineal 12-core prostate biopsyParticipants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test. | Diagnostic test | Participants with elevated or rising PSA |
Primary outcome
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
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
7 secondary outcomes
Cancer Detection Rate
Time frame: duration of study, average 3 months
csPCa Detection Rate
Time frame: duration of study, average 3 months
Biopsy aversion rate
Time frame: duration of study, average 3 months
Net Benefit
Time frame: duration of study, average 3 months
Diagnostic Accuracy
Time frame: duration of study, average 3 months
Positive Predictive Value (PPV)
Time frame: duration of study, average 3 months
Negative Predictive Value (NPV)
Time frame: duration of study, average 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikhil Waingankar, MD principal investigator
Icahn School of Medicine at Mount Sinai
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urinary ExoDx test, Transrectal ultrasound-guided prostate biopsy and Transperineal 12-core prostate biopsy in people with Prostate Cancer, run by Icahn School of Medicine at Mount Sinai at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikhil Waingankar, MD ((718) 808-7777, nikhil.waingankar@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: duration of study, average 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.