ExoDx Prostate Evaluation in Active Surveillance Patient Population

October 5, 2022 updated by: Exosome Diagnostics, Inc.
The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.

Study Type

Observational

Enrollment (Anticipated)

750

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Chesapeake Urology
        • Contact:
          • Emily Ayre

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Description

Inclusion Criteria:

  • Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Exclusion Criteria:

  • Clinical symptoms of urinary tract infection at time of enrollment.
  • History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
  • Known hepatitis or HIV
  • History of concurrent renal/bladder tumors

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Develop and evaluate risk-based scoring using the ExoDx Prostate test.
Time Frame: 1yr after last enrolled patient
1yr after last enrolled patient

Collaborators and Investigators

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

Sponsor

Exosome Diagnostics, Inc.

Investigators

  • Study Director: Sonia Kumar, PhD, Exosome Diagnostics, Inc.

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)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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