Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

September 29, 2021 updated by: Exosome Diagnostics, Inc.

Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany
        • Klinikum der Universität München
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Chesapeake Urology Research Associates
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • New Jersey Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

- Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml scheduled for an initial biopsy

Description

Inclusion Criteria:

  • Clinical suspicion for prostate cancer
  • Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
  • Scheduled for a initial prostate biopsy

Exclusion Criteria:

  • 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.
  • Known hepatitis status (all types) and/or HIV documented in patient's medical record.
  • Patients with history of concurrent renal/bladder tumors.
  • Prior MRI used in the decision to biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exosome Diagnostics, Inc.

Investigators

  • Study Director: Mikkel Noerholm, Exosome Diagnostics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT2020-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD can be shared on an individual basis. Please reach out for more information.

IPD Sharing Time Frame

12 months after trial completion

IPD Sharing Access Criteria

Individual basis upon mutual agreement

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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