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TerminatedNCT04357717Updated Mar 31, 2022

ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

An observational study in Prostate Cancer, sponsored by Exosome Diagnostics, Inc.. Terminated at 2 sites in United States. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Exosome Diagnostics, Inc. · Observational

Why this study was terminated
project reprioritization
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
50 Years and older
Sex
Male
01

Study summary

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.

Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.

Read the detailed description

Primary Endpoint:

Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.

Secondary Endpoints (exploratory):

  1. Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
  2. Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
  3. Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.
  4. Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.
02

Conditions studied

  • Prostate Cancer

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Keywords

  • exosome
  • ExoDx Prostate
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 150 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Exosome Diagnostics, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml and at least one prior negative prostate biopsy

Inclusion criteria

  • 50+ years of age
  • Clinical suspicion for prostate cancer
  • Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
  • At least one (1) prior negative prostate biopsy

Exclusion criteria

Exclusion Criteria:

  • Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
  • Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
  • History of prostate cancer.
  • History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
  • No known hepatitis status (all types) and/or HIV documented in patient's medical record.
  • Patients with history of concurrent renal/bladder tumors.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testExoDx Prostate

    Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml

06

What researchers measure

Primary outcomes

  1. Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.

    Time frame: 6 months

07

Study locations

2 sites
  • Chesapeake Urology Research Associates
    Baltimore, Maryland 21204, United States
  • New Jersey Urology
    Voorhees, New Jersey 08043, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04357717
Lead sponsor
Exosome Diagnostics, Inc.
Responsible party
Sponsor
First posted
Apr 22, 2020
Start date
Mar 15, 2020
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021
Last update
Mar 31, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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