ExosomeDx Test for Prostate Cancer

Recruiting at 5 trial locations

Overseen By Nikhil Waingankar, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

425 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nikhil Waingankar, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Men with high PSA levels but negative MRI results for prostate cancer are eligible. The trial is designed to determine if a urine test (ExoDx) can better identify who really needs a biopsy, potentially avoiding unnecessary procedures and their risks.

Inclusion Criteria

Willingness to participate and provide signed and dated informed consent form

PSA ≥ 2.0 ng/mL and ≤ 10.0 ng/mL

I am male.

Exclusion Criteria

Prior transrectal ultrasound within the last 5 years

I have not been diagnosed with any cancer in the last 5 years.

I am mentally capable of making my own health decisions and following study rules.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

ExoDx Testing

Participants with elevated PSA and negative MRI undergo ExoDx urine test to assess risk stratification

1 week

1 visit (in-person)

Biopsy Procedure

Participants undergo transrectal ultrasound-guided or transperineal 12-core prostate biopsy as per standard diagnostic practice

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy and ExoDx testing

3 months

Treatment Details

Interventions

• ExosomeDx

Trial Overview The study tests the ExoDx Prostate test, which analyzes urinary exosomes for specific gene signatures as an alternative to invasive biopsies in men with high PSA but negative MRIs. It aims to improve risk assessment and decision-making about biopsies.

Participant Groups

Group I: Participants with elevated or rising PSA Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Bio-Techne Corporation

Collaborator