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Completed

NCT Number: NCT04720599

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.

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Key information

Conditions

Urologic Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Klinikum der Universität München, München, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ExoDx Prostate(IntelliScore)

Diagnostic Test

The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer

Other names: EPI, EPI-CE

Primary outcomes

  1. Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Exosome Diagnostics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2021
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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