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

Urologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720599
• Other study ID #: ECT2020-002
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2020
• Source: Exosome Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urologic Cancer
• Urologic Neoplasms

Intervention

Diagnostic Test:
• ExoDx Prostate(IntelliScore)
The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer

Locations

Country	Name	City	State
Germany	Klinikum der Universität München	München
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	New Jersey Urology	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Exosome Diagnostics, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.		1 year