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Article History

Received: 26 January 2024

Revised: 28 March 2024

Accepted: 10 April 2024

First Online: 6 June 2024

Compliance with ethical standards

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: The scientific guarantor of this publication Naoki Takahashi.

: The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.

: No complex statistical methods were necessary for this paper.

: Written informed consent was waived by the Institutional Review Board. “The Reviewer approved waiver of the requirement to obtain informed consent in accordance with 45 CFR 46.116 as justified by the Investigator, and waiver of HIPAA authorization in accordance with applicable HIPAA regulations”.

: Institutional Review Board approval was obtained. (#23-008038). “IRB Application #: 23-008038. Title: Development of Machine Learning Model of Prostate Cancer Using Prostate MRI and Clinical Data. IRB Approval Date: 8/30/2023. IRB Expiration Date: The above referenced application was reviewed by expedited review procedures and is determined to be exempt from the requirement for IRB approval (45 CFR 46.104d, category 4). Continued IRB review of this study is not required as it is currently written. However, requests for modifications to the study design or procedures must be submitted to the IRB to determine whether the study continues to be exempt. The Reviewer approved waiver of HIPAA authorization in accordance with applicable HIPAA regulations. As the principal investigator of this project, you are responsible for the following relating to this study. (1) When applicable, use only IRB approved materials which are located under the documents tab of the IRBe workspace. Materials include consent forms, HIPAA, questionnaires, contact letters, advertisements, etc. (2) Submission to the IRB of any modifications to approved research along with any supporting documents for review and approval prior to initiation of the changes. (3) Submission to the IRB of all Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) and major protocol violations/deviations within five working days of becoming aware of the occurrence. (4) Compliance with applicable regulations for the protection of human subjects and with Mayo Clinic Institutional Policies. Mayo Clinic Institutional Reviewer”.

: Thousands of patients included in this study overlapped with previously published works that evaluated cancer detection rates of prostate MRI in various different populations and a study that developed deep learning models for detecting clinically significant prostate cancer.

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