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PRospective Prostate biOmarker Study

NCT ID: NCT03565289

Last Updated: 2020-12-16

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

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Recruitment Status

COMPLETED

Total Enrollment

455 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-14

Study Completion Date

2020-01-31

Brief Summary

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• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness

Detailed Description

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The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.

Conditions

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Indication for Prostate Biopsy Due to Suspected Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

All

Blood sample collection

Intervention Type DIAGNOSTIC_TEST

During a routine blood draw an additional tube of blood will be taken for the study.

Interventions

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Blood sample collection

During a routine blood draw an additional tube of blood will be taken for the study.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Male patient between 45 and 80 years old.
* tPSA between 2 and 10 ng/ml
* Prostate volume \>=35 ml
* Non-suspicious DRE for prostate cancer
* Scheduled for prostate biopsy
* Patient must give written informed consent

Exclusion Criteria

* Patient not undergoing biopsy of the prostate
* Prior prostate biopsy within the last 12 months
* Transurethral resection of the prostate (TURP) in the last 5 years
* Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities
* Patient taking 5-alpha-reductase inhibitor
* Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ProteoMediX AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Steuber, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Martiniklinik am UKE gGmbH

Locations

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Ordensklinikum Linz

Linz, Upper Austria, Austria

Site Status

Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, Germany

Site Status

Helios Klinikum Bad Saarow

Bad Saarow, , Germany

Site Status

Malteser Krankenhaus Bonn/Rhein-Sieg

Bonn, , Germany

Site Status

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, , Germany

Site Status

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Site Status

Martini Klinik am UKE GmbH

Hamburg, , Germany

Site Status

Marien-Hospital Herne

Herne, , Germany

Site Status

Daikonie Klinikum Stuttgart

Stuttgart, , Germany

Site Status

Countries

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Austria Denmark Germany

Other Identifiers

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PROPOSe_1

Identifier Type: -

Identifier Source: org_study_id