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

NCT04720599 | Completed

• 1 other identifier: ECT2020-002
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Urologic Cancer

Keywords

exosome; ExoDx Prostate

Outcome Measures

Primary Outcomes (1)

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

  1 year

Interventions

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

Also known as: EPI, EPI-CE

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Participants with prostates
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exosome Diagnostics, Inc.: lead

Study Sites (3)

Chesapeake Urology Research Associates

Baltimore, Maryland, 21204, United States

Location

New Jersey Urology

Voorhees Township, New Jersey, 08043, United States

Location

Klinikum der Universität München

München, Germany

Location

Related Publications (2)

• Kretschmer A, Kajau H, Margolis E, Tutrone R, Grimm T, Trottmann M, Stief C, Stoll G, Fischer CA, Flinspach C, Albrecht A, Meyer L, Priewasser T, Enderle D, Muller R, Torkler P, Alter J, Skog J, Noerholm M. Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy. Sci Rep. 2022 Mar 21;12(1):4777. doi: 10.1038/s41598-022-08608-z.

  PMID: 35314720 DERIVED

• Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27.

  PMID: 35084544 DERIVED

MeSH Terms

Conditions

Urologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mikkel Noerholm

  Exosome Diagnostics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 30, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 12 months after trial completion
• Access Criteria: Individual basis upon mutual agreement

Locations

DE (1); US (2)