PRospective Prostate biOmarker Study (PROPOSe)

PRospective Prostate biOmarker Study

Sponsors

Lead sponsor: ProteoMediX AG

Source 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.

Overall Status Active, not recruiting
Start Date August 14, 2018
Completion Date January 31, 2020
Primary Completion Date December 31, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Diagnosis of PCA 6 months
Aggressiveness of PCA 6 months
Diagnosis of PCA 12 months
Aggressiveness of PCA 12 months
Enrollment 455
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Blood sample collection

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

Arm group label: All patients

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.)

Gender: Male

Minimum age: 45 Years

Maximum age: 80 Years

Overall Official
Last Name Role Affiliation
Thomas Steuber, Prof. Dr. Principal Investigator Martiniklinik am UKE gGmbH
Location
facility
Ordensklinikum Linz | Linz, Oberösterreich, 6020, Austria
Medizinische Universität Innsbruck | Innsbruck, 6020, Austria
Rigshospitalet | Copenhagen, 2200, Denmark
Universitätsklinikum Münster | Münster, NRW, 48149, Germany
Helios Klinikum Bad Saarow | Bad Saarow, 15526, Germany
Malteser Krankenhaus Bonn/Rhein-Sieg | Bonn, 53123, Germany
Städtisches Klinikum Braunschweig gGmbH | Braunschweig, 38126, Germany
Universitätsklinikum Frankfurt | Frankfurt, 60590, Germany
Martini Klinik am UKE GmbH | Hamburg, 20246, Germany
Marien-Hospital Herne | Herne, 44625, Germany
Daikonie Klinikum Stuttgart | Stuttgart, 70176, Germany
Location Countries

Austria

Denmark

Germany

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: All patients

Description: All

Acronym PROPOSe
Patient Data No
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov