PRospective Prostate biOmarker Study

Completed

• Conditions: Indication for Prostate Biopsy Due to Suspected Prostate Cancer
• Interventions: Diagnostic Test: Blood sample collection

• Registration Number: NCT03565289
• Lead Sponsor: ProteoMediX AG

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-06-07
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2018-08-14
• Primary Completion: 2019-12-31
• Study Completion: 2020-01-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 455

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Blood sample collection	All

Primary Outcome Measures

Name	Time	Method
Diagnosis of PCA	12 months	Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa
Aggressiveness of PCA	12 months	Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa

Trial Locations

Locations (11)

Malteser Krankenhaus Bonn/Rhein-Sieg; 🇩🇪 Bonn, Germany

Marien-Hospital Herne; 🇩🇪 Herne, Germany

Martini Klinik am UKE GmbH; 🇩🇪 Hamburg, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Daikonie Klinikum Stuttgart; 🇩🇪 Stuttgart, Germany

Ordensklinikum Linz; 🇦🇹 Linz, Oberösterreich, Austria

Städtisches Klinikum Braunschweig gGmbH; 🇩🇪 Braunschweig, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, NRW, Germany

Helios Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria