MedDataX Logo

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

NCT ID: NCT04720599

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urologic Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

exosome ExoDx Prostate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ExoDx Prostate(IntelliScore)

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EPI EPI-CE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Exosome Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mikkel Noerholm

Role: STUDY_DIRECTOR

Exosome Diagnostics, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

Site Status

New Jersey Urology

Voorhees Township, New Jersey, United States

Site Status

Klinikum der Universität München

München, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35314720 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35084544 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECT2020-002

Identifier Type: -

Identifier Source: org_study_id