Zurich-Schlieren, Switzerland, October 5, 2023. Proteomedix, a Swiss diagnostics company committed to advance prostate cancer care, today announced that new results evaluating Proclarix® in the diagnostic work-up of prostate cancer at the University Hospital Zurich were published in BJUI Compass 1).
The use of multiparametric magnetic resonance imaging (mpMRI) has been widely adopted in the diagnostic work-up for suspicious prostate cancer (PCa) and is recommended in most current guidelines. However, mpMRI lesions are often indeterminate and/or turn out to be false-positive on prostate biopsy. The aim of this work was to evaluate Proclarix, a biomarker test for the detection of relevant PCa, regarding its diagnostic value in all men before biopsy and in men with indeterminate lesions on mpMRI (PI-RADS 3) during work-up for PCa.
A total of 150 men from University Hospital Zurich (USZ) with a median age of 65 years and median PSA of 5.8 ng/mL were included in this study. CsPCa (clinically significant PCa) was diagnosed in 65 (43%) men. Proclarix was significantly associated with csPCa and higher score from mpMRI (p < 0.001). Proclarix density showed the highest accuracy for the detection of csPCa when compared to PSA, PSAD and Proclarix alone.
Importantly, Proclarix was able to identify all six csPCa in men with indeterminant mpMRI lesions (n = 28), whereas PSA density (PSAD) missed two out of six. At optimized cut-offs, Proclarix density outperformed PSAD by potentially avoiding 41% of unnecessary biopsies.
”In the patient population with PI-RADS 3 findings, Proclarix density could potentially reduce the need for unnecessary prostate biopsies in this subgroup, while still allowing for sufficient detection of csPCa.” Dr. med. Basil Kaufmann and PD Dr. med. Cédric Poyet from USZ commented: “This study shows the potential of combining imaging and a serum biomarker such as Proclarix in the field of risk stratification for men with suspected prostate cancer. Combining different risk tools such as clinical risk calculator including PSA, imaging and further biomarkers will help us in the future to better select men who do really need a prostate biopsy.”
Proclarix® is CE-certified under IVDR and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer.
Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis. The company has identified novel biomarker signatures with utility in prostate cancer diagnosis, prognosis and therapy management. The lead product Proclarix is a blood based prostate cancer test panel and risk score currently available in Europe. Proteomedix is located in the Bio-Technopark of Zurich-Schlieren, Switzerland. For more information, visit www.proteomedix.com.
For further details, please contact:
Dr. Ralph Schiess, CEO
1) Kaufmann, B. et al. Evaluation of Proclarix in the diagnostic work‐up of prostate cancer. BJUI Compass (2023) doi:10.1002/bco2.293.