Clinical Utility of 4Kscore, ExosomeDx and Magnetic Resonance Imaging for the Early Detection of High-Grade Prostate Cancer.

We aimed to evaluate 4Kscore and ExosomeDx with multiparametric magnetic resonance imaging (mpMRI) in the detection of high-grade prostate cancer (PCa) and number of biopsies avoided.

Patients had one liquid biomarker test with or without mpMRI. High-grade PCa was defined as Gleason grade group (GG) ≥2. The overall number of avoided biopsies (with GG≤1), and number of missed GG≥2 cancer among the biopsied patients, were determined.

Of the 783 patients in the overall cohort, 419 (53.5%) underwent biopsy. 4Kscore and ExosomeDx scores higher than the manufacturers' cut point were associated with PI-RADS scores 3-5 and GG≥2 PCa. Limiting biopsy to the men with liquid biomarker scores above the manufacturers' cut point would have resulted avoiding 29.5-39.9% unnecessary biopsies overall, while missing 4.0-4.8% GG≥2 PCa in the biopsy group. Screening algorithms with upfront liquid biomarker testing followed by mpMRI if the biomarker is above the manufacturers' cut point, then followed by biopsy if the mpMRI is positive or if 4Kscore≥20 or ExosomeDx≥19 would have missed 4.8-5.6% of GG≥2 PCa in the biopsy group while avoiding 39.4-43.0% biopsies and 29.5-39.9% mpMRIs overall. Similar algorithms with upfront mpMRI followed by liquid biomarker testing for negative mpMRIs would have missed 2.4% of GG≥2 PCa in the biopsy group but only avoided 17.2-19.3% biopsies overall.

Screening algorithms with upfront liquid biomarker testing followed by mpMRI and biopsy at certain biomarker thresholds could reduce unnecessary biopsies, mpMRI, and over detection of GG1 PCa.

The Journal of urology. 2020 Sep 08 [Epub ahead of print]

Claire M de la Calle, Vittorio Fasulo, Janet E Cowan, Peter E Lonergan, Martina Maggi, Adam J Gadzinski, Reuben Au Yeung, Alberto Saita, Matthew R Cooperberg, Katsuto Shinohara, Peter R Carroll, Hao G Nguyen

Department of Urology, Helen Diller Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA, USA., Department of Urology, Humanitas Clinical and Research Center (IRCCS) Rozzano, Italy.