Clinical use of the SelectMDx urinary-biomarker test with or without mpMRI in prostate cancer diagnosis: a prospective, multicenter study in biopsy-naïve men

• Published in: Prostate cancer and prostatic diseases 2021-12, Vol.24 (4), p.1110-1119
• Main Authors: Hendriks, Rianne J., van der Leest, Marloes M. G., Israël, Bas, Hannink, Gerjon, YantiSetiasti, Anglita, Cornel, Erik B., Hulsbergen-van de Kaa, Christina A., Klaver, O. Sjoerd, Sedelaar, J. P. Michiel, Van Criekinge, Wim, de Jong, Hans, Mulders, Peter F. A., Crawford, E. David, Veltman, Jeroen, Schalken, Jack A., Barentsz, Jelle O., van Oort, Inge M.
• Format: Article
• Language: English
• Subjects: 45/77; 59/57; 631/67/589/466; 692/308/53/2421; 692/53/2421; 692/699/2768/589/466; Aged; Antigens; Biomarkers; Biomarkers, Tumor - urine; Biomedical and Life Sciences; Biomedicine; Biopsy; Cancer; Cancer Research; Decision analysis; Diagnosis; Diagnostic imaging; Humans; Image-Guided Biopsy - methods; Magnetic resonance imaging; Magnetic Resonance Imaging, Interventional; Male; Medical tests; Middle Aged; Multiparametric Magnetic Resonance Imaging; Neoplasm Grading; Oncology, Experimental; Patient Selection; Patients; Prospective Studies; Prostate cancer; Prostate-specific antigen; Prostatic Neoplasms - diagnostic imaging; Prostatic Neoplasms - pathology; Prostatic Neoplasms - urine; Reproductive Medicine; Risk; Risk Assessment; Strategy; Ultrasonography, Interventional
• ISSN: 1365-7852; 1476-5608
• DOI: 10.1038/s41391-021-00367-8

Background Risk stratification in men with suspicion of prostate cancer (PCa) requires reliable diagnostic tests, not only to identify high-grade PCa, also to minimize the overdetection of low-grade PCa, and reduction of “unnecessary” prostate MRIs and biopsies. This study aimed to evaluate the SelectMDx test to detect high-grade PCa in biopsy-naïve men. Subsequently, to assess combinations of SelectMDx test and multi-parametric (mp) MRI and its potential impact on patient selection for prostate biopsy. Methods This prospective multicenter diagnostic study included 599 biopsy-naïve patients with prostate-specific antigen level ≥3 ng/ml. All patients underwent a SelectMDx test and mpMRI before systematic transrectal ultrasound-guided biopsy (TRUSGB). Patients with a suspicious mpMRI also had an in-bore MR-guided biopsy (MRGB). Histopathologic outcome of TRUSGB and MRGB was used as reference standard. High-grade PCa was defined as ISUP Grade Group (GG) ≥ 2. The primary outcome was the detection rates of low- and high-grade PCa and number of biopsies avoided in four strategies, i.e., (1) SelectMDx test-only, (2) mpMRI-only, (3) SelectMDx test followed by mpMRI when SelectMDx test was positive (conditional strategy), and (4) SelectMDx test and mpMRI in all (joint strategy). A positive SelectMDx test outcome was a risk score of ≥−2.8. Decision curve analysis (DCA) was performed to assess clinical utility. Results Prevalence of high-grade PCa was 31% (183/599). Thirty-eight percent (227/599) of patients had negative SelectMDx test in whom biopsy could be avoided. Low-grade PCa was not detected in 35% (48/138) with missing 10% (18/183) high-grade PCa. Yet, mpMRI-only could avoid 49% of biopsies, not detecting 4.9% (9/183) of high-grade PCa. The conditional strategy reduces the number of mpMRIs by 38% (227/599), avoiding biopsy in 60% (357/599) and missing 13% (24/183) high-grade PCa. Low-grade PCa was not detected in 58% (80/138). DCA showed the highest net benefit for the mpMRI-only strategy, followed by the conditional strategy at-risk thresholds >10%. Conclusions SelectMDx test as a risk stratification tool for biopsy-naïve men avoids unnecessary biopsies in 38%, minimizes low-grade PCa detection, and misses only 10% high-grade PCa. Yet, using mpMRI in all patients had the highest net benefit, avoiding biopsy in 49% and missing 4.9% of high-risk PCa. However, if mpMRI availability is limited or expensive, using mpMRI-only in SelectMDx test positive patients is