Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
425 participants
INTERVENTIONAL
2025-08-31
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Urinary ExoDx test
A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
Transrectal ultrasound-guided prostate biopsy
Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary 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.
Interventions
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Urinary ExoDx test
A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
Transrectal ultrasound-guided prostate biopsy
Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary 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.
Eligibility Criteria
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Inclusion 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
* 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)
18 Years
MALE
No
Sponsors
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Bio-Techne Corporation
UNKNOWN
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Nikhil Waingankar
Associate Professor
Principal Investigators
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Nikhil Waingankar, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY-24-00010
Identifier Type: -
Identifier Source: org_study_id
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