PRospective Prostate biOmarker Study (PROPOSe)

ProteoMediX

Status: Completed

Conditions: Indication for Prostate Biopsy Due to Suspected Prostate Cancer

Treatments: Diagnostic Test: Blood sample collection

Study type: Observational

Funder types: Industry

Identifiers

NCT03565289

PROPOSe_1

Details and patient eligibility

About

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

Full 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.

Enrollment: 455 patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

455 participants in 1 patient group

All patients

Description:

All

Treatment:

Diagnostic Test: Blood sample collection