ExosomeDx Test for Prostate Cancer

Not yet 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

Must not be taking: Immunosuppressants

Disqualifiers: Prostate cancer, Prior cancer, Coagulopathy, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance decision-making for doctors regarding prostate biopsies in men with high PSA levels, an invasive test with certain risks. The current method, which uses MRI scans, sometimes misses cases that might require a biopsy. The trial will evaluate a new urine-based test called ExosomeDx, which could improve decision-making by providing a more accurate prediction. Men with high PSA levels but a clear MRI scan might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to research that could refine diagnostic methods and potentially reduce unnecessary procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the ExosomeDx test is safe for patients with elevated PSA?

Research has shown that the ExosomeDx (ExoDx) test is easy for patients to handle. This non-invasive test does not require surgery or needles, making it safer than a traditional biopsy. The ExoDx test uses a urine sample to assess prostate cancer risk, helping to avoid procedures that might cause infections.

Studies have demonstrated that this test can accurately detect significant prostate cancer. It assists doctors in deciding whether a biopsy is necessary, reducing unnecessary biopsies and their associated risks. Overall, medical studies have proven the ExoDx test to be safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

ExosomeDx is unique because it offers a non-invasive way to assess prostate cancer risk using exosomes, which are tiny particles released by cells that carry important genetic information. Unlike the standard care options, such as PSA testing and MRI, which can sometimes lead to unnecessary biopsies, ExosomeDx provides a more precise analysis of prostate cancer likelihood by examining the molecular content in a urine sample. Researchers are excited about this approach because it could reduce the number of unnecessary invasive procedures and help doctors make more informed decisions about patient care.

What evidence suggests that the ExosomeDx test is effective for improving risk stratification in prostate cancer?

Studies have shown that the ExoDx Prostate test, which participants in this trial will undergo, can greatly improve the accuracy of predicting high-grade prostate cancer. Research indicates that this urine-based test is 90% effective at ruling out cancer when the result is negative. This is particularly beneficial for men with high PSA levels (a blood marker for prostate issues) who have had a negative MRI, as it aids in deciding whether a biopsy (a tissue sample check) is necessary. In comparison, an MRI alone is only 77% effective at ruling out cancer, making ExoDx more reliable for confirming when a biopsy can be safely skipped. The test examines specific gene markers in urine, providing a less invasive method to assess cancer risk. ^{1 4 6 7 8}

Who Is on the Research Team?

Nikhil Waingankar, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. exosomedx.com exosomedx.com/physicians/exodx-prostate-test

ExoDx™ Prostate Test The data from the trials demonstrated a statistically significant improvement in the ability to accurately predict high-grade prostate cancer in men presenting ...

2. exosomedx.com exosomedx.com/patients/elevated-psa-levels

What Causes Elevated PSA Levels However, if the PSA level is over 10 ng/ml, then the chance of having prostate cancer is over 50%. Additional data points can help to identify high risk cancers ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7466797/

A urine-based Exosomal gene expression test stratifies risk of ... ExoDx Prostate demonstrated good performance ruling out high-grade (Grade group 2, GG2, or higher) prostate cancer (HGPCa) using the previously validated 15.6 ...

4. exosomedx.com exosomedx.com/sites/default/files/2024-09/exodx-prostate-test-2.5-year-study-predictor-of-outcomes-of-high-grade-prostate-cancer.pdf

exodx-prostate-test-2.5-year-study-predictor-of-outcomes- ... PSA screening allows for early detection of tumors but is very non- specific and elevated PSAs are often the result of benign prostatic.

5. exosomedx.com exosomedx.com/

ExosomeDx: Exosome Based Liquid Biopsy for Prostate ... A standalone, exosome-based prostate cancer test delivering a unique data point to help guide the prostate biopsy decision.

6. nature.com nature.com/articles/s41391-023-00675-1

ExoDx prostate test as a predictor of outcomes of high- ... PSA screening allows for early detection of tumors but is very non-specific and elevated PSAs are often the result of benign prostatic ...

7. exosomedx.com exosomedx.com/europe/node/97946

ExoDx Prostate Cancer Test Patient Information The EPI-CE test provides a risk assessment for finding clinically significant prostate cancer that otherwise relies on biopsy in men with an elevated PSA.

8. exosomedx.com exosomedx.com/sites/default/files/2023-04/exodx-sample-test-report.pdf

ExoDx™ PROSTATE TEST - PATIENT REPORT The ExoDx Prostate Test, or EPI is a risk assessment tool. A score below 15.6 indicates a lower risk of high-grade prostate cancer (≥GG2) with a sensitivity ...