ExosomeDx in MRI-negative Men With High PSA

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06966089
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
425 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Sensitivity [ Time Frame: duration of study, average 3 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Mount Sinai Beth Israel / Union SquareNew YorkNew York10003
Michael Palese (SUB_INVESTIGATOR)
Mount Sinai BrooklynNew YorkNew York11234
Nikhil Waigankar (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10029
Nikhil Waingankar, MD
[email protected]
718-808-7777
Nikhil Waigankar (PRINCIPAL_INVESTIGATOR)
Mount Sinai MorningsideNew YorkNew York10025-
Mount Sinai QueensNew YorkNew York11102
Nikhil Waigankar (SUB_INVESTIGATOR)
Mount Sinai WestNew YorkNew York10019
Craig Nobert (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Mount Sinai Beth Israel / Union Square· New York, NYMount Sinai Brooklyn· New York, NYMount Sinai Hospital· New York, NYMount Sinai Morningside· New York, NYMount Sinai Queens· New York, NYMount Sinai West· New York, NY

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