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NCT06966089 · ClinicalTrials.gov registry record · NA
ExosomeDx in MRI-negative Men With High PSA
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Not yet
- Registry status
- NA
- Development phase
- 425
- Enrollment target
NCT06966089 is a NA study that has not yet begun recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 425 participants.
The verdict
NCT06966089, a NA study, has not yet begun recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 425 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Urinary ExoDx test
- DIAGNOSTIC_TEST Transrectal ultrasound-guided prostate biopsy
- DIAGNOSTIC_TEST Transperineal 12-core prostate biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2025-08 |
| Est. Completion | 2026-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06966089
The ClinicalTrials.gov registry entry for NCT06966089 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Urinary ExoDx test is the first listed.
NCT06966089 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06966089 about?
NCT06966089 is a clinical study titled "ExosomeDx in MRI-negative Men With High PSA". 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 predicti...
What is the current status of trial NCT06966089?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 425 participants. The study started on 2025-08. Estimated completion is 2026-08.
What interventions are being tested in trial NCT06966089?
The interventions under investigation include: Urinary ExoDx test (DEVICE), Transrectal ultrasound-guided prostate biopsy (DIAGNOSTIC_TEST), Transperineal 12-core prostate biopsy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06966089?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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