PRospective Prostate biOmarker Study

ProteoMediX AG455 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

455

Conditions

Indication for Prostate Biopsy Due to Suspected Prostate Cancer

Interventions

Blood sample collectionDIAGNOSTIC_TEST

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

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.)

Locations (11)

Ordensklinikum Linz

Linz, Upper Austria, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Diagnosis of PCA

Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa

Time frame: 6 months

Aggressiveness of PCA

Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa

Time frame: 6 months

Diagnosis of PCA

Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa

Time frame: 12 months

Aggressiveness of PCA

Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa

Time frame: 12 months

Data from ClinicalTrials.gov

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