ExosomeDx in MRI-negative Men With High PSA

Official title

Evaluation of Urinary Exosomes as a Risk Stratification Tool Among Men With Elevated PSAs and Negative Prostate MRIs

Overview

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
  A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
• Diagnostic test Transrectal ultrasound-guided prostate biopsy
  Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.
• Diagnostic 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.

Primary outcome measures

• Sensitivity [Time frame: duration of study, average 3 months]
• Specificity [Time frame: duration of study, average 3 months]

Secondary outcome measures (7)

• Cancer Detection Rate [Time frame: duration of study, average 3 months]
• csPCa Detection Rate [Time frame: duration of study, average 3 months]
• Biopsy aversion rate [Time frame: duration of study, average 3 months]
• Net Benefit [Time frame: duration of study, average 3 months]
• Diagnostic Accuracy [Time frame: duration of study, average 3 months]
• Positive Predictive Value (PPV) [Time frame: duration of study, average 3 months]
• Negative Predictive Value (NPV) [Time frame: duration of study, average 3 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 6 centers

• Mount Sinai Beth Israel / Union Square — New York
• Mount Sinai West — New York
• Mount Sinai Morningside — New York
• Mount Sinai Hospital — New York
• Mount Sinai Queens — New York
• Mount Sinai Brooklyn — New York

Identifiers

NCT: NCT06966089 · STUDY-24-00010

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗