Abstract
Background: Prostate MRI is used widely in clinical care for guiding tissue sampling, active surveillance, and staging. The Prostate Imaging Reporting and Data System (PI-RADS) helps provide a standardized probabilistic approach for identifying clinically significant prostate cancer. Despite widespread use, the variability in performance of prostate MRI across practices remains unknown. Purpose: To estimate the positive predictive value (PPV) of PI-RADS for the detection of high-grade prostate cancer across imaging centers. Materials and Methods: This retrospective cross-sectional study was compliant with the HIPAA. Twenty-six centers with members in the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel submitted data from men with suspected or biopsy-proven untreated prostate cancer. MRI scans were obtained between January 2015 and April 2018. This was followed with targeted biopsy. Only men with at least one MRI lesion assigned a PI-RADS score of 2–5 were included. Outcome was prostate cancer with Gleason score (GS) greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2). A mixed-model logistic regression with institution and individuals as random effects was used to estimate overall PPVs. The variability of observed PPV of PI-RADS across imaging centers was described by using the median and interquartile range. Results: The authors evaluated 3449 men (mean age, 65 years 6 8 [standard deviation]) with 5082 lesions. Biopsy results showed 1698 cancers with GS greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2) in 2082 men. Across all centers, the estimated PPV was 35% (95% confidence interval [CI]: 27%, 43%) for a PI-RADS score greater than or equal to 3 and 49% (95% CI: 40%, 58%) for a PI-RADS score greater than or equal to 4. The interquartile ranges of PPV at these same PI-RADS score thresholds were 27%–44% and 27%–48%, respectively. Conclusion: The positive predictive value of the Prostate Imaging and Reporting Data System was low and varied widely across centers.
Original language | English (US) |
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Pages (from-to) | 76-84 |
Number of pages | 9 |
Journal | Radiology |
Volume | 296 |
Issue number | 1 |
DOIs | |
State | Published - Jul 2020 |
Bibliographical note
Funding Information:This investigator-initiated pragmatic retrospective multicenter cross-sectional study of PI-RADS was compliant with the Health Insurance Portability and Accountability Act. The study protocol was approved by each participating institution’s committee on human research, and the requirement to obtain written informed consent was waived. Four authors reported potential conflicts of interest (listed at the end of the article). This project was supported by a seed grant from the Department of Radiology and Biomedical Imaging, University of California, San Francisco, and the Clinical and Translational Science Institute, University of California, San Francisco. The funders had no influence on the design or conduct of the study and were not involved in data collection or analysis, in the writing of the manuscript, or in the decision to submit it for publication. No industry support was received for this project.
Funding Information:
article: has received grant funding from the University of California, San Francisco. Activities not related to the present article: receives payment for board membership from 3D Biopsy; has grants/grants pending with GE Healthcare. Other relationships: disclosed no relevant relationships. C.E.M. Activities related to the present article: author’s institution has received grant funding from the National Institutes of Health. Activities not related to the present article: disclosed no relevant relationships. Other relationships: disclosed no relevant relationships. J.M.A. disclosed no relevant relationships. S.A. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: has grants/grants pending with RSNA; has a patent planned, pending, or issued; has received reimbursement for travel/accommodations/meeting expenses from Profound. Other relationships: disclosed no relevant relationships. N.S.B. disclosed no relevant relationships. J.O.B. disclosed no relevant relationships. T.K.B. disclosed no relevant relationships. L.K.B. disclosed no relevant relationships. M.T.B. disclosed no relevant relationships. V.G.B. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: received an honorarium from Profound Medical for participating in a usability study. Other relationships: disclosed no relevant relationships. P.R.C. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: serves on the board of Nutcracker Therapeutics; is a consultant for Insightec. Other relationships: disclosed no relevant relationships. D.D.C. disclosed no relevant relationships. S.D.C. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: has received payment for lectures, including service on speakers bureaus, from TerSera Therapeutics. Other relationships: disclosed no relevant relationships. F.V.C. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: is a founder of and stockholder in OmnEcoil Instruments. Other relationships: disclosed no relevant relationships. R.D. disclosed no relevant relationships. S.C.E. disclosed no relevant relationships. B.R.F. disclosed no relevant relationships. A.T.F. disclosed no relevant relationships. J.J.F. disclosed no relevant relationships. D.M.G. disclosed no relevant relationships. M.R.G. disclosed no relevant relationships. L.M.G. disclosed no relevant relationships. S.G. disclosed no relevant relationships. R.T.G. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: is a consultant for InVivo. Other relationships: disclosed no relevant relationships. M.E.H. disclosed no relevant relationships. R.H. disclosed no relevant relationships. C.K. disclosed no relevant relationships. C.K.K. disclosed no relevant relationships. C.L. disclosed no relevant relationships. D.J.A.M. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: is a consultant for Blue Earth Diagnostics; author’s institution has grants/grants pending with Siemens Healthineers; has received payment for the development of educational presentations for the British Columbia Radiological Society. Other relationships: disclosed no relevant relationships. S.E.M. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: is a consultant for Cook Medical. Other relationships: disclosed no relevant relationships. A.O. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: received payment for board membership from Profound Healthcare; has grants/grants pending with Guerbet, Philips, and Profound. Other relationships: disclosed no relevant relationships. R.B.P. disclosed no relevant relationships. N.U.P. disclosed no relevant relationships. P.A.P. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: has patents planned, pending, or issued with the National Institutes of Health and Philips; receives royalties for a licensing agreement with Philips/InVivo. Other relationships: disclosed no relevant relationships. T.J.P. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: receives payment for lectures, including service on speakers bureaus, from Endocare. Other relationships: disclosed no relevant relationships. B.S. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: is a consultant for Francis Medical. Other relationships: disclosed no relevant relationships. J.B.S. disclosed no relevant relationships. V.S.T. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: has received reimbursement for travel/accommodations/meeting expenses from Profound Medical. Other relationships: disclosed no relevant relationships. S.S.T. disclosed no relevant relationships. B.T. disclosed no relevant relationships. S.V. disclosed no relevant relationships. J.F.W. disclosed no relevant relationships. C.A.W. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: has received reimbursement for travel/accommodations/meeting expenses from Ningbao Hospital No. 2. Other relationships: disclosed no relevant relationships. A.R.W. disclosed no relevant relationships. J.Y. disclosed no relevant relationships. R.J.Z. disclosed no relevant relationships. A.B.R. Activities related to the present article: disclosed no relevant relationships. Activities not related to the present article: receives royalties from Thieme Medical Publishers. Other relationships: disclosed no relevant relationships.
Funding Information:
This project was supported by a seed grant from the Department of Radiology and Biomedical Imaging, University of California, San Francisco (grant 16-43) and Clinical and Translational Science Institute, University of California, San Francisco (grant UL1 TR001872).
Publisher Copyright:
© RSNA, 2020.
Keywords
- Aged
- Cross-Sectional Studies
- Humans
- Magnetic Resonance Imaging/methods
- Male
- Predictive Value of Tests
- Prostate/diagnostic imaging
- Prostatic Neoplasms/diagnostic imaging
- Radiology Information Systems
- Reproducibility of Results
- Retrospective Studies
- Societies, Medical
PubMed: MeSH publication types
- Research Support, Non-U.S. Gov't
- Multicenter Study
- Journal Article
- Research Support, N.I.H., Extramural