A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer
Purpose: We report herein the 3-year results of a phase I/II prospective study of 4-fraction course of carbon-ion radiation therapy (CIRT) in patients with localized prostate cancer. Methods and Materials: The present was a single-institution, phase I/II prospective study including patients with low...
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Elsevier
2025-03-01
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| Series: | Advances in Radiation Oncology |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2452109424002689 |
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| author | Noriyuki Okonogi, MD, PhD Hiroshi Tsuji, MD, PhD Kana Kobayashi, MD, PhD Mio Nakajima, MD, PhD Shuri Aoki, MD, PhD Takanobu Utsumi, MD, PhD Hiroyoshi Suzuki, MD, PhD Koichiro Akakura, MD, PhD Tomohiko Ichikawa, MD, PhD Hitoshi Ishikawa, MD, PhD |
| author_facet | Noriyuki Okonogi, MD, PhD Hiroshi Tsuji, MD, PhD Kana Kobayashi, MD, PhD Mio Nakajima, MD, PhD Shuri Aoki, MD, PhD Takanobu Utsumi, MD, PhD Hiroyoshi Suzuki, MD, PhD Koichiro Akakura, MD, PhD Tomohiko Ichikawa, MD, PhD Hitoshi Ishikawa, MD, PhD |
| author_sort | Noriyuki Okonogi, MD, PhD |
| collection | DOAJ |
| description | Purpose: We report herein the 3-year results of a phase I/II prospective study of 4-fraction course of carbon-ion radiation therapy (CIRT) in patients with localized prostate cancer. Methods and Materials: The present was a single-institution, phase I/II prospective study including patients with low- or intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network criteria. Eligible patients were randomly assigned (1:1) to a 1- or 2-week schedule. Dose-limiting toxicities (DLTs) were defined as any genitourinary (GU) or gastrointestinal (GI) toxicity grade 3 or higher within 90 days of beginning CIRT. Ten patients were enrolled in each group, and the CIRT dose was increased in a stepwise manner if there were fewer than 4 cases of DLT. The initial CIRT dose was 36 Gy, followed by 40 Gy or 44 Gy. Low-risk patients did not receive androgen deprivation therapy (ADT), whereas intermediate-risk patients received 4 to 8 months of neoadjuvant ADT. Results: Between October 2018 and October 2020, 60 patients were enrolled in the present study and completed the treatment regimen. The median post-CIRT follow-up period was 42 months (range, 27-59 months). Of the 60 patients enrolled, 10 were in the low-risk group, and 50 were in the intermediate-risk group. Neither group experienced grade 3 or higher GI or GU adverse events; therefore, no dose-limiting toxicities were observed. The incidence of grade 2 GU toxicity within 90 days post CIRT was significantly higher in the 44 Gy group than in the 36 to 40 Gy group (P < .01, chi-square test with Yates correction). Biochemical failure was observed in 3 cases by 3 years post CIRT. No clinical recurrence or death because of prostate cancer occurred. Conclusions: Forty Gy in 4 fractions of CIRT may be appropriate for balancing the therapeutic effects and toxicity. Our findings support further investigations into the efficacy of this strategy. |
| format | Article |
| id | doaj-art-728804069b73499ab0e76b32616189fa |
| institution | Kabale University |
| issn | 2452-1094 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
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| series | Advances in Radiation Oncology |
| spelling | doaj-art-728804069b73499ab0e76b32616189fa2025-02-06T05:12:37ZengElsevierAdvances in Radiation Oncology2452-10942025-03-01103101705A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate CancerNoriyuki Okonogi, MD, PhD0Hiroshi Tsuji, MD, PhD1Kana Kobayashi, MD, PhD2Mio Nakajima, MD, PhD3Shuri Aoki, MD, PhD4Takanobu Utsumi, MD, PhD5Hiroyoshi Suzuki, MD, PhD6Koichiro Akakura, MD, PhD7Tomohiko Ichikawa, MD, PhD8Hitoshi Ishikawa, MD, PhD9QST Hospital, National Institute for Quantum Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba City, Chiba, 263-8555, Japan; Department of Radiation Oncology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, JapanQST Hospital, National Institute for Quantum Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba City, Chiba, 263-8555, Japan; Corresponding author: Hiroshi Tsuji, MD, PhDQST Hospital, National Institute for Quantum Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba City, Chiba, 263-8555, JapanQST Hospital, National Institute for Quantum Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba City, Chiba, 263-8555, JapanQST Hospital, National Institute for Quantum Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba City, Chiba, 263-8555, JapanDepartment of Urology, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba 285-8741, JapanDepartment of Urology, Toho University Sakura Medical Center, 564-1 Shimoshizu, Sakura-shi, Chiba 285-8741, JapanDepartment of Urology, Japan Community Health Care Organization Mishima General Hospital, 2276 Fujikubo, Yata, Mishima, Shizuoka 411-0801, JapanDepartment of Urology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JapanQST Hospital, National Institute for Quantum Science and Technology, 4-9-1 Anagawa, Inage-ku, Chiba City, Chiba, 263-8555, JapanPurpose: We report herein the 3-year results of a phase I/II prospective study of 4-fraction course of carbon-ion radiation therapy (CIRT) in patients with localized prostate cancer. Methods and Materials: The present was a single-institution, phase I/II prospective study including patients with low- or intermediate-risk prostate cancer, as defined by the National Comprehensive Cancer Network criteria. Eligible patients were randomly assigned (1:1) to a 1- or 2-week schedule. Dose-limiting toxicities (DLTs) were defined as any genitourinary (GU) or gastrointestinal (GI) toxicity grade 3 or higher within 90 days of beginning CIRT. Ten patients were enrolled in each group, and the CIRT dose was increased in a stepwise manner if there were fewer than 4 cases of DLT. The initial CIRT dose was 36 Gy, followed by 40 Gy or 44 Gy. Low-risk patients did not receive androgen deprivation therapy (ADT), whereas intermediate-risk patients received 4 to 8 months of neoadjuvant ADT. Results: Between October 2018 and October 2020, 60 patients were enrolled in the present study and completed the treatment regimen. The median post-CIRT follow-up period was 42 months (range, 27-59 months). Of the 60 patients enrolled, 10 were in the low-risk group, and 50 were in the intermediate-risk group. Neither group experienced grade 3 or higher GI or GU adverse events; therefore, no dose-limiting toxicities were observed. The incidence of grade 2 GU toxicity within 90 days post CIRT was significantly higher in the 44 Gy group than in the 36 to 40 Gy group (P < .01, chi-square test with Yates correction). Biochemical failure was observed in 3 cases by 3 years post CIRT. No clinical recurrence or death because of prostate cancer occurred. Conclusions: Forty Gy in 4 fractions of CIRT may be appropriate for balancing the therapeutic effects and toxicity. Our findings support further investigations into the efficacy of this strategy.http://www.sciencedirect.com/science/article/pii/S2452109424002689 |
| spellingShingle | Noriyuki Okonogi, MD, PhD Hiroshi Tsuji, MD, PhD Kana Kobayashi, MD, PhD Mio Nakajima, MD, PhD Shuri Aoki, MD, PhD Takanobu Utsumi, MD, PhD Hiroyoshi Suzuki, MD, PhD Koichiro Akakura, MD, PhD Tomohiko Ichikawa, MD, PhD Hitoshi Ishikawa, MD, PhD A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer Advances in Radiation Oncology |
| title | A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer |
| title_full | A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer |
| title_fullStr | A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer |
| title_full_unstemmed | A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer |
| title_short | A Phase I/II Study of Ultra-Hypofractionated Carbon-ion Radiation therapy for Low- and Intermediate-Risk Localized Prostate Cancer |
| title_sort | phase i ii study of ultra hypofractionated carbon ion radiation therapy for low and intermediate risk localized prostate cancer |
| url | http://www.sciencedirect.com/science/article/pii/S2452109424002689 |
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