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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: Clinical Trial NA study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What is known before NCT06966089 opens enrollment
NCT06966089 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Urinary ExoDx test is the first listed.
NCT06966089 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06966089's enrollment target sits among peer trials
425 236th of 2000 higher than 1,763 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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