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Purpose <p>To prospectively determine the incidence of grade 2 acute genitourinary (GU) toxicity after hypofractionated proton beam therapy (PBT) for localized prostate cancer.</p> Methods <p>The protocol was approved by the institutional review board (IRB). Patients received 51.6&#xa0;Gy (relative biological effectiveness (RBE)) delivered in 12 fractions over 3&#xa0;weeks. The primary endpoint was the incidence of grade ≥ 2 acute GU toxicities within 3&#xa0;months. Neoadjuvant androgen deprivation therapy (ADT) was administered to the intermediate-risk group, and neoadjuvant and adjuvant ADT were administered to high-risk group classified according to the National Comprehensive Cancer Network (NCCN) guideline.</p> Results <p>From March 2021 to June 2024, 100 patients underwent hypofractionated PBT. The incidence of grade 2 acute GU toxicities (urinary frequency) was 8% (95% confidence interval [CI] 2.6–13.4), meeting the pre-specified continuation criterion. No grade ≥ 3 acute GU toxicities were observed. Furthermore, no grade ≥ 2 acute urinary retention, urinary pain, urinary urgency or hematuria were observed. Univariate analysis preliminarily suggested that compared with the high-risk group patients, the low- and/or intermediate-risk group patients had a higher trend of grade 2 GU toxicities (OR: 0.265 (95% CI 0.066–1.062), P = 0.055). Multivariate regression analysis further confirmed that the high-risk classification was associated with a significantly lower risk grade 2 GU toxicities (OR: 0.023 (95% CI 0.002–0.840), P = 0.042). Additionally, multivariate regression analysis confirmed that benign prostatic hyperplasia (BPH) was an independent influencing factor for grade 2 GU toxicity (OR: 0.040 (95% CI 0.003–0.582), P = 0.018).</p> Conclusions <p>Our results indicate that hypofractionated PBT&#xa0;(51.6&#xa0;Gy [RBE] in 12 fractions over 3&#xa0;weeks)&#xa0;for localized prostate cancer provides&#xa0;acceptable acute GU toxicity rates.&#xa0;Long-term follow-up of the 300-patient expansion cohort is underway to evaluate late toxicities and long-term oncological efficacy.</p>

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Analysis of acute genitourinary toxicity in hypofractionated proton beam therapy for localized prostate cancer

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月3日

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  • Wencui Yang,
  • Junetsu Mizoe,
  • Yasuhiro Osaka,
  • Yasuhide Miyabe,
  • Hiroto Seki,
  • Hirotaka Nakamura,
  • Hiromi Sugawara,
  • Naoto Miyajima,
  • Hiromitsu Iwata,
  • Takayuki Hashimoto,
  • Ritsuko Komaki

摘要

Purpose

To prospectively determine the incidence of grade 2 acute genitourinary (GU) toxicity after hypofractionated proton beam therapy (PBT) for localized prostate cancer.

Methods

The protocol was approved by the institutional review board (IRB). Patients received 51.6 Gy (relative biological effectiveness (RBE)) delivered in 12 fractions over 3 weeks. The primary endpoint was the incidence of grade ≥ 2 acute GU toxicities within 3 months. Neoadjuvant androgen deprivation therapy (ADT) was administered to the intermediate-risk group, and neoadjuvant and adjuvant ADT were administered to high-risk group classified according to the National Comprehensive Cancer Network (NCCN) guideline.

Results

From March 2021 to June 2024, 100 patients underwent hypofractionated PBT. The incidence of grade 2 acute GU toxicities (urinary frequency) was 8% (95% confidence interval [CI] 2.6–13.4), meeting the pre-specified continuation criterion. No grade ≥ 3 acute GU toxicities were observed. Furthermore, no grade ≥ 2 acute urinary retention, urinary pain, urinary urgency or hematuria were observed. Univariate analysis preliminarily suggested that compared with the high-risk group patients, the low- and/or intermediate-risk group patients had a higher trend of grade 2 GU toxicities (OR: 0.265 (95% CI 0.066–1.062), P = 0.055). Multivariate regression analysis further confirmed that the high-risk classification was associated with a significantly lower risk grade 2 GU toxicities (OR: 0.023 (95% CI 0.002–0.840), P = 0.042). Additionally, multivariate regression analysis confirmed that benign prostatic hyperplasia (BPH) was an independent influencing factor for grade 2 GU toxicity (OR: 0.040 (95% CI 0.003–0.582), P = 0.018).

Conclusions

Our results indicate that hypofractionated PBT (51.6 Gy [RBE] in 12 fractions over 3 weeks) for localized prostate cancer provides acceptable acute GU toxicity rates. Long-term follow-up of the 300-patient expansion cohort is underway to evaluate late toxicities and long-term oncological efficacy.