Proclarix: A Promising Tool for Prostate Cancer Detection

What is it about?

The study evaluated Proclarix, a biomarker test for the detection of relevant prostate cancer (PCa), regarding its diagnostic value in all men before biopsy and in men with indeterminate lesions on multiparametric magnetic resonance imaging (mpMRI) during work-up for PCa. The test was found to have a sensitivity of 94% and a negative predictive value of 80% for the detection of clinically significant PCa (csPCa), but a low specificity of 19%, resulting in many unnecessary biopsies. Proclarix density showed the highest area under the curve (AUC) for the detection of csPCa of 0.77 compared to PSA, PSAD, and Proclarix alone. In the subgroup of men with indeterminate PI-RADS 3 lesions, Proclarix achieved a sensitivity and negative predictive value of 100%, outperforming PSAD, while its specificity at 14% was again relatively low.

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Why is it important?

This research is important because it evaluates the diagnostic value of Proclarix, a biomarker test for the detection of relevant prostate cancer (PCa), in men before biopsy and in men with indeterminate lesions on multiparametric magnetic resonance imaging (mpMRI) during work-up for PCa. The use of mpMRI has been widely adopted in the diagnostic work-up for suspicious 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. Thus, there is a need for better diagnostic tools to identify clinically significant PCa (csPCa) before biopsy. Proclarix demonstrated high sensitivity in detecting csPCa but may still result in unnecessary biopsies. However, when adjusted to prostate volume (Proclarix density), it outperformed PSA density and Proclarix alone, and it was found to be useful in men with PI-RADS 3 findings by safely avoiding unnecessary biopsies without missing csPCa. Key Takeaways: 1. Proclarix is a biomarker test for the detection of relevant PCa. 2. Proclarix demonstrated high sensitivity in detecting csPCa but may still result in unnecessary biopsies. 3. Proclarix density outperformed PSA density and Proclarix alone for csPCa detection. 4. Proclarix density was found to be useful in men with PI-RADS 3 findings by safely avoiding unnecessary biopsies without missing csPCa.