Michele Fascelli1, Soroush Rais-Bahrami2, Sandeep Sankineni3, Anna M Brown3, Arvin K George1, Richard Ho1, Thomas Frye1, Amichai Kilchevsky1, Raju Chelluri1, Steven Abboud1, M Minhaj Siddiqui4, Maria J Merino5, Bradford J Wood6, Peter L Choyke3, Peter A Pinto7, Baris Turkbey8. 1. Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD. 2. Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD; Departments of Urology and Radiology, University of Alabama at Birmingham, Birmingham, AL. 3. Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD. 4. Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD; Department of Surgery, Division of Urology, University of Maryland, Baltimore, MD. 5. Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, MD. 6. Center for Interventional Oncology, Department of Radiology and Imaging Services, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD. 7. Center for Interventional Oncology, Department of Radiology and Imaging Services, NIH Clinical Center and National Cancer Institute, National Institutes of Health, Bethesda, MD; Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD. 8. Molecular Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD. Electronic address: ismail.turkbey@nih.gov.
Abstract
OBJECTIVE: To validate the use of biparametric (T2- and diffusion-weighted) magnetic resonance imaging (B-MRI) and prostate-specific antigen (PSA) or PSA density (PSAD) in a biopsy-naive cohort at risk for prostate cancer (PCa). METHODS: All patients (n = 59) underwent PSA screening and digital rectal exam prior to a B-MRI followed by MRI or transrectal ultrasound fusion-guided targeted biopsy. Previously reported composite formulas incorporating screen positive lesions (SPL) on B-MRI and PSA or PSAD were developed to maximize PCa detection. For PSA, a patient was considered screen positive if PSA level + 6 × (the number of SPL) >14. For PSAD, screening was positive if PSAD × 14 + (the number of SPL) >4.25. These schemes were employed in this new test set to validate the initial formulas. Performance assessment of these formulas was determined for all cancer detection and for tumors with Gleason ≥3 + 4. RESULTS: Screen positive lesions on B-MRI had the highest sensitivity (95.5%) and negative predictive value of 71.4% compared with PSA and PSAD. B-MRI significantly improved sensitivity (43.2-72.7%, P = .0002) when combined with PSAD. The negative predictive value of PSA increased with B-MRI, achieving 91.7% for B-MRI and PSA for Gleason ≥3 + 4. Overall accuracies of the composite equations were 81.4% (B-MRI and PSA) and 78.0% (B-MRI and PSAD). CONCLUSION: Validation with a biopsy-naive cohort demonstrates the parameter SPL performed better than PSA or PSAD alone in accurately detecting PCa. The combined use of B-MRI, PSA, and PSAD resulted in improved accuracy for detecting clinically significant PCa. Published by Elsevier Inc.
OBJECTIVE: To validate the use of biparametric (T2- and diffusion-weighted) magnetic resonance imaging (B-MRI) and prostate-specific antigen (PSA) or PSA density (PSAD) in a biopsy-naive cohort at risk for prostate cancer (PCa). METHODS: All patients (n = 59) underwent PSA screening and digital rectal exam prior to a B-MRI followed by MRI or transrectal ultrasound fusion-guided targeted biopsy. Previously reported composite formulas incorporating screen positive lesions (SPL) on B-MRI and PSA or PSAD were developed to maximize PCa detection. For PSA, a patient was considered screen positive if PSA level + 6 × (the number of SPL) >14. For PSAD, screening was positive if PSAD × 14 + (the number of SPL) >4.25. These schemes were employed in this new test set to validate the initial formulas. Performance assessment of these formulas was determined for all cancer detection and for tumors with Gleason ≥3 + 4. RESULTS: Screen positive lesions on B-MRI had the highest sensitivity (95.5%) and negative predictive value of 71.4% compared with PSA and PSAD. B-MRI significantly improved sensitivity (43.2-72.7%, P = .0002) when combined with PSAD. The negative predictive value of PSA increased with B-MRI, achieving 91.7% for B-MRI and PSA for Gleason ≥3 + 4. Overall accuracies of the composite equations were 81.4% (B-MRI and PSA) and 78.0% (B-MRI and PSAD). CONCLUSION: Validation with a biopsy-naive cohort demonstrates the parameter SPL performed better than PSA or PSAD alone in accurately detecting PCa. The combined use of B-MRI, PSA, and PSAD resulted in improved accuracy for detecting clinically significant PCa. Published by Elsevier Inc.
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