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Clinical value of prostate health index as an indicator for recommending magnetic resonance imaging in patients with gray-zone prostate-specific antigen level

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Abstract

Purpose

To evaluate the usefulness of prostate health index (PHI) as an indicator for recommending magnetic resonance imaging (MRI) in patients with prostate-specific antigen (PSA) gray zone level < 10 ng/mL.

Methods

443 patients who underwent prostate biopsy (PB) after serum PHI test and MRI between April 2019 and December 2022 were enrolled. For patients with visible lesion on MRI with Prostate Imaging Reporting and Data System Score (PI-RADS) ≥ 3, MRI-targeted PB was performed in addition to systematic 12-core PB.

Results

The optimal cutoff value of PHI for predicting PI-RADS ≥ 3 lesions was 39.6, which was significantly associated with overall prostate cancer (OR 3.07, p = 0.018) and clinically significant prostate cancer (csPCa) (OR 4.15, p = 0.006) at MRI-targeted PB cores. When MRI was restricted to patients with PHI ≥ 39.6 alone, 28.7% of unnecessary MRI could be saved at the cost of missing 13.6% of csPCa. When omitting MRI for patients with PHI < 39.6 and PSAD < 0.12 ng/mL2, unnecessary MRI could be reduced by 20.1% with the risk of missing 6.2% of csPCa. With addition of systematic PB, 21.0% of patients with negative MRI-targeted PB were diagnosed as csPCa.

Conclusions

For patients in PSA gray zone, PHI of 39.6 might be an indicator for MRI and further MRI-targeted PB in additional to PSAD of 0.12 ng/mL2, reducing 20.1% of unnecessary MRI with the minimal risk of missing 6.2% of csPCa. To maximize csPCa detection, combining both MRI-targeted and systematic PB should be also considered.

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Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

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Acknowledgements

This work was supported by a grant of Korea Medical Device Development Fund funded by the Korea government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health & Welfare, the Ministry of Food and Drug Safety) (Project Number: 1711138269 , RS-2020-KD000141) (NTIS, RS-2020-KD000141).

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Authors and Affiliations

  1. Department of Urology, Seoul National University Bundang Hospital, 166, Gumi-ro, Bundang-gu, Seongnam, 13620, Gyunggi-Do, Korea

    Byeongdo Song, Sang Hun Song, Hakmin Lee, Sung Kyu Hong, Seok-Soo Byun & Sangchul Lee

  2. Seoul National University College of Medicine, Seoul, Korea

    Sung Il Hwang, Hak Jong Lee, Hakmin Lee, Sung Kyu Hong, Seok-Soo Byun & Sangchul Lee

  3. Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Korea

    Sung Il Hwang & Hak Jong Lee

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  1. Byeongdo Song
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Contributions

BS and SL contributed to protocol/project development; BS analyzed the data; BS and SL contributed to manuscript writing/editing; SHS, SIH and HJL were involved in data collection/analysis/management; HL, SKH and SSB were involved in the critical review; SL supervised the study.

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Correspondence to Sangchul Lee.

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Conflict of interest

Our research was conducted without commercial or financial relationships that could be interpreted as a potential conflict of interest. The authors declare that there is no potential conflict of interest.

Research involving human participants and/or animals

The Seoul National University Bundang Hospital Institutional Review Board (IRB) approved this study (IRB no. B-2304-825-103). Our research does not include animals as subjects. 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.

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The requirement of written informed consent was waived due to the retrospective nature of this study.

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Song, B., Song, S.H., Hwang, S.I. et al. Clinical value of prostate health index as an indicator for recommending magnetic resonance imaging in patients with gray-zone prostate-specific antigen level. World J Urol 41, 3519–3526 (2023). https://doi.org/10.1007/s00345-023-04613-7

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