Abstract
Purpose
To evaluate the negative predictive value (NPV) of a negative prostate multi-parametric magnetic resonance imaging (mpMRI) in ruling out clinically significant prostate upon 12-core systematic biopsy.
Methods
We retrospectively reviewed 114 men evaluated at our institution who underwent systematic 12-core biopsy within 1 year of a negative prostate mpMRI. Clinicopathologic features were evaluated and NPV was calculated for detection of clinically significant (Gleason ≥ 7) cancer. Regression analysis was performed to identify clinical predictors of biopsy outcome.
Results
Overall, 88 (77.2%) patients in our cohort had no cancer detected upon biopsy. The highest pathologic grade was Gleason 6 (3 + 3) in 22 (19.3%) patients, and Gleason ≥ 7 in 4 (3.6%) patients. NPV for detecting Gleason ≥ 7 cancer was 96.5% (95% CI 93.1–99.9%) in the entire negative MRI cohort, 100% in those who were prostate biopsy naïve (n = 20), 100% in those with a prior negative biopsy (n = 53), and 90% in those who have had a previous positive biopsy and on active surveillance (n = 41). Regression analysis identified no predictors of significant cancer in our cohort.
Conclusion
In our cohort of men with no lesions detected on prostate mpMRI, we found very low rates of clinically significant cancer on systematic 12-core biopsy. In the few patients who diagnosed with prostate cancer, the majority had low-risk disease and could remain on active surveillance. Although validation studies and greater sample size is needed before clinical recommendations can be made, our data suggest patients with negative mpMRI evaluated by experienced radiologists may avoid unnecessary prostate biopsy and potential overtreatment.
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Acknowledgements
This research was supported by the Intramural Research Program of the NIH, National Cancer Institute, Center for Cancer Research and the National Institutes of Health (NIH) Medical Research Scholars Program, a public–private partnership supported jointly by the NIH and generous contributions to the Foundation for the NIH from the Doris Duke Charitable Foundation, The American Association for Dental Research, the Colgate-Palmolive Company, Genentech and alumni of student research programs and other individual supporters via contributions to the Foundation for the National Institutes of Health.
Funding
This research was supported by the Intramural Research Program of the NIH, National Cancer Institute, Center for Cancer Research and the National Institutes of Health (NIH) Medical Research Scholars Program, a public–private partnership supported jointly by the NIH and generous contributions to the Foundation for the NIH from the Doris Duke Charitable Foundation, The American Association for Dental Research, the Colgate-Palmolive Company, Genentech and alumni of student research programs and other individual supporters via contributions to the Foundation for the National Institutes of Health.
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Author BJW is supported by the Intramural Research Program of the NIH and the NIH Center for Interventional Oncology and NIH Grant # Z1A CL040015-08. NIH and Philips/InVivo Inc have a cooperative Research and Development Agreement. NIH and Philips/InVivo Inc have a patent license agreement and NIH and BJW, BT, PAP, PLC may receive royalties.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.
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Informed consent was obtained from all individual participants included in the study.
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Baris Turkbey and Peter A. Pinto have shared senior authorship.
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An, J.Y., Sidana, A., Holzman, S.A. et al. Ruling out clinically significant prostate cancer with negative multi-parametric MRI. Int Urol Nephrol 50, 7–12 (2018). https://doi.org/10.1007/s11255-017-1715-7
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DOI: https://doi.org/10.1007/s11255-017-1715-7