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A Japanese multi-institutional phase II study of moderate hypofractionated intensity-modulated radiotherapy with image-guided technique for prostate cancer

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Abstract

Background

The aim of this multi-institutional phase II study was to confirm the safety and the potential efficacy of moderately hypofractionated intensity-modulated radiotherapy (IMRT) with prostate-based image-guidance for Japanese patients.

Methods

Patients with low- or intermediate-risk localized prostate cancer were eligible. Patients with a part of high risk (having only one of the following factors, cT3a, 20 < PSA ≤ 30, or GS = 8 or 9) were also included. Hypofractionated IMRT using daily image-guided technique with prostate matching was performed with a total dose of 70 Gy in 28 fractions. Neoadjuvant hormonal therapy for 4–8 months was mandatory for patients with intermediate or high-risk prostate cancer.

Results

From 20 institutions, 134 patients enrolled. The median follow-up was 5.16 years (range, 1.43–6.47 years). The number of patients with low, intermediate, and high-risk prostate cancer was 20, 80, and 34, respectively. The 5-year overall, biochemical failure-free, and clinical failure-free survival was 94.5%, 96.0%, and 99.2%, respectively. The 5-year biochemical failure-free survival for patients with low-, intermediate-, and high-risk disease was 94.1%, 97.4%, and 93.9%, respectively. The incidences of grade 2 gastrointestinal (GI) and genitourinary (GU) late toxicities at 5 years were 5.3% and 5.3%, respectively. There are no acute or late toxicities ≥ grade 3. Of 124 patients who were followed for up to 5 years, the grade 2 late GU or GI toxicities were 10.5% (90% confidence intervals, 6.3–16.2%, p = 0.0958).

Conclusion

The safety and efficacy of moderately hypofractionated IMRT with prostate-based image-guidance was confirmed among Japanese patients with prostate cancer.

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Data availability

The data that support the findings of this study are available on request from the corresponding author, K.N. The data are not publicly available due to their containing information that could compromise the privacy of research participants.

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Acknowledgements

This work was supported by a Health Labor Sciences Research Grant (H24-ganrinsho-ippan-007) from the Ministry of Health, Labor and Welfare of Japan.

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Authors and Affiliations

  1. Department of Radiation Oncology, Hamamatsu University School of Medicine, Handayama 1-20-1, Higashi-ku, Hamamatsu, 431-3192, Japan

    Katsumasa Nakamura

  2. Osaka Medical and Pharmaceutical University, Osaka, Japan

    Keiji Nihei

  3. Saitama Cancer Center, Saitama, Japan

    Yoshihiro Saito

  4. Graduate School of Medicine, Juntendo University, Tokyo, Japan

    Naoto Shikama

  5. International Medical Center, Saitama Medical University, Saitama, Japan

    Shin-ei Noda

  6. Chiba Cancer Centre, Chiba, Japan

    Ryusuke Hara

  7. Kobe City Medical Center General Hospital, Hyogo, Japan

    Toshiyuki Imagumbai

  8. Kyoto University, Kyoto, Japan

    Takashi Mizowaki

  9. Tokai University School of Medicine, Kanagawa, Japan

    Takeshi Akiba & Etsuo Kunieda

  10. Sapporo Medical University School of Medicine, Sapporo, Japan

    Masanori Someya

  11. Kyushu Medical Center, Fukuoka, Japan

    Saiji Ohga

  12. St. Luke’s International Hospital, Tokyo, Japan

    Jiro Kawamori

  13. Toranomon Hospital, Tokyo, Japan

    Takuyo Kozuka

  14. Hyogo Cancer Center, Hyogo, Japan

    Yosuke Ota

  15. National Cancer Center Hospital, Tokyo, Japan

    Koji Inaba

  16. Aichi Cancer Center Hospital, Aichi, Japan

    Takeshi Kodaira

  17. Anjo Kosei Hospital, Aichi, Japan

    Yoshiyuki Itoh

  18. Kyushu University Hospital, Fukuoka, Japan

    Kouta Funakoshi

  19. Showa University School of Medicine, Tokyo, Japan

    Yoshikazu Kagami

Authors
  1. Katsumasa Nakamura
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  2. Keiji Nihei
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  3. Yoshihiro Saito
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  4. Naoto Shikama
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  5. Shin-ei Noda
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  6. Ryusuke Hara
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  7. Toshiyuki Imagumbai
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  8. Takashi Mizowaki
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  9. Takeshi Akiba
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  10. Etsuo Kunieda
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  11. Masanori Someya
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  12. Saiji Ohga
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  13. Jiro Kawamori
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  14. Takuyo Kozuka
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  15. Yosuke Ota
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  16. Koji Inaba
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  17. Takeshi Kodaira
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  18. Yoshiyuki Itoh
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  19. Kouta Funakoshi
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  20. Yoshikazu Kagami
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Katsumasa Nakamura and Kouta Funakoshi. The first draft of the manuscript was written by Katsumasa Nakamura and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Katsumasa Nakamura.

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Nakamura, K., Nihei, K., Saito, Y. et al. A Japanese multi-institutional phase II study of moderate hypofractionated intensity-modulated radiotherapy with image-guided technique for prostate cancer. Int J Clin Oncol (2024). https://doi.org/10.1007/s10147-024-02517-z

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  • DOI: https://doi.org/10.1007/s10147-024-02517-z

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