TEST:

Proclarix®

P=N/A, N=480, Recruiting, Kantonsspital Aarau

This manuscript describes the characteristics and diagnostic performance of each biomarker alone and in combination with mpMRI, with the intension to provide a basis for decision-making in the diagnosis and treatment of HGPCa. Additionally, we explored the applicability of the combination protocol to the Asian population.

The demand for mpMRI decreased by 19.9%, prostate biopsies by 19.8%, and over-detection of iPCa by 22.7%, while 2.6% of csPCa remained undetected as in the recommended RSP. Cost-effectiveness remained when the Proclarixâ„¢ price was assumed to be below EUR 200.

Proclarix demonstrates high sensitivity in detecting csPCa but may still result in unnecessary biopsies. However, Proclarix density was able to outperform PSAD and Proclarix and was found to be useful in men with PI-RADS 3 findings by safely avoiding unnecessary biopsies without missing csPCa.

It is recommended to establish a multidisciplinary team that takes into account factors such as age, PSAD, prostate, and lesion size, as well as previous biopsy pathological findings. Combining expert opinions, clinical-imaging indicators, and emerging methods will contribute to the development of management strategies for PI-RADS 3 lesions.

"Proteomedix...announced that new results evaluating Proclarix® in the diagnostic work-up of prostate cancer at the University Hospital Zurich were published in BJUI Compass...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."

"Proteomedix...announced today that it entered into an agreement for Labcorp, a leading global life sciences company, to be the only laboratory to develop and commercialize the Proclarix® Prostate Specific Antigen (PSA) test in the U.S.. Proclarix is performed using the same blood sample as a PSA test, and is designed to help determine the risk of clinically significant prostate cancer for men with an elevated total PSA and a digital rectal examination that indicates elevated prostate volume, but who are not suspected of having cancer. In appropriate cases, the test provides a non-invasive alternative to a prostate biopsy, which can have significant side effects."

There is a correlation between Proclarix and the aggressiveness of PCa.

"Proteomedix...announced that Proclarix® has been included in the 2023 clinical practice guideline for the early detection of prostate cancer of the American Urology Association (AUA), in partnership with the Society of Urologic Oncology (SUO)."

"Proteomedix...announced that Proclarix® has been included in the 2023 European Association of Urology (EAU) Guidelines for the diagnostic evaluation of prostate cancer."

Our preliminary study suggests that combining PHI and PCLX biomarkers may help to estimate, with higher accuracy, the presence of csPCa at initial diagnosis, allowing a personalized treatment approach. Further studies training the model on larger datasets are strongly encouraged to support the efficiency of this approach.

"Proteomedix...announced that new results evaluating Proclarix® in combination with imaging were published in BJU International...The aim of the study highlighted here was the assessment of the diagnostic performance of Proclarix in combination with mpMRI."

When combined with mpMRI and prostate volume, Proclarix reliably predicted csPCa and ruled out men with no or indolent cancer. A large reduction of two thirds of unneeded biopsies was achieved. Proclarix can further be used with high confidence to reliably detect csPCa in men with an indeterminate PI-RADS 3 mpMRI. Despite these encouraging results, further validation is needed.

"Proteomedix...announced that is has received IVDR certification for its prostate cancer diagnostic test Proclarix® from TÜV SÜD...The new In Vitro Diagnostic Regulation (IVDR) recently replaced the IVD Directive. Under the IVDR, diagnostic products are categorized under a new system of one of four classifications from class A (low risk) to class D (highest risk). Proclarix as class C was assessed by TÜV SÜD for conformity resulting in IVDR certification."