Onconetix’s Proclarix® Demonstrates High Accuracy In Prostate Cancer Diagnosis, Avoiding Unnecessary Biopsies

Onconetix, Inc., formerly known as Blue Water Biotech, Inc. (BWV), the company announced data from a new clinical study of Proclarix®. The data was presented at the 2025 European Association of Urology (EAU) Congress on March 23, 2025. The findings from the study validate the strong clinical performance of Proclarix® in a Danish patient cohort, supporting its potential as an advanced diagnostic tool for prostate cancer detection.

Prostate cancer is typically detected by measuring prostate-specific antigen (PSA) levels in the blood. However, PSA testing lacks specificity, leading to overdiagnosis and unnecessary biopsies. Proclarix® aims to improve diagnostic accuracy by reducing false positives and identifying only clinically significant prostate cancers.

Primary investigator and presenter of the study, Ahmed H. Zedan, MD, PhD from Lillebaelt Hospital,  University Hospital of Southern Denmark, commented, “Proclarix can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer and minimising the risk of missing clinically significant cancer”.

In a study was performed on 808 patients suspected to have prostate cancer, Proclarix® showed superior diagnostic accuracy. Among 371 patients with enlarged prostates, a negative Proclarix® test indicated a 5% or lower probability of clinically significant cancer, outperforming %fPSA (14%) and the ERSPC risk calculator (20%). Proclarix® also helped avoid 22% of biopsies while missing only 3 out of 101 cases of significant cancer. In an expanded cohort of 654 patients with PSA levels between 2-20 ng/ml, Proclarix® demonstrated 96% sensitivity and a significantly higher specificity (p<0.001) compared to other diagnostic tools.