ExosomeDx in MRI-negative Men With High PSA

Mount Sinai Health System

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Device: Urinary ExoDx test; Diagnostic Test: Transrectal ultrasound-guided prostate biopsy; Diagnostic Test: Transperineal 12-core prostate biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06966089

STUDY-24-00010

Details and patient eligibility

About

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.

Enrollment: 425 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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
  • 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

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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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425 participants in 1 patient group

Participants with elevated or rising PSA

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Transperineal 12-core prostate biopsy

Diagnostic Test: Transrectal ultrasound-guided prostate biopsy

Device: Urinary ExoDx test