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A Single-Institution Prospective Study To Evaluate the Safety and Efficacy of Real-Time Image-Gated Spot-Scanning Proton Therapy (RGPT) for Prostate Cancer

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Title: A Single-Institution Prospective Study To Evaluate the Safety and Efficacy of Real-Time Image-Gated Spot-Scanning Proton Therapy (RGPT) for Prostate Cancer
Authors: Nishioka, Kentaro Browse this author →KAKEN DB
Hashimoto, Takayuki Browse this author →KAKEN DB
Mori, Takashi Browse this author
Uchinami, Yusuke Browse this author
Kinoshita, Rumiko Browse this author
Katoh, Norio Browse this author
Taguchi, Hiroshi Browse this author
Yasuda, Koichi Browse this author
Ito, Yoichi M. Browse this author
Takao, Seishin Browse this author
Tamura, Masaya Browse this author
Matsuura, Taeko Browse this author →KAKEN DB
Shimizu, Shinichi Browse this author →KAKEN DB
Shirato, Hiroki Browse this author →KAKEN DB
Aoyama, Hidefumi Browse this author →KAKEN DB
Issue Date: May-2024
Journal Title: Advances in Radiation Oncology
Volume: 9
Issue: 5
Start Page: 101464
Publisher DOI: 10.1016/j.adro.2024.101464
Abstract: Purpose: In real-time image-gated spot-scanning proton therapy (RGPT), the dose distribution is distorted by gold fiducial markers placed in the prostate. Distortion can be suppressed by using small markers and more than 2 fields, but additional fields may increase the dose to organs at risk. Therefore, we conducted a prospective study to evaluate the safety and short-term clinical outcome of RGPT for prostate cancer. Methods and Materials: Based on the previously reported frequency of early adverse events (AE) and the noninferiority margin of 10%, the required number of cases was calculated to be 43 using the one-sample binomial test by the Southwest Oncology Group statistical tools with the one-sided significance level of 2.5% and the power 80%. Patients with localized prostate cancer were enrolled and 3 to 4 pure gold fiducial markers of 1.5-mm diameter were inserted in the prostate. The prescribed dose was 70 Gy(relative biologic effectiveness) in 30 fractions, and treatment was performed with 3 fields from the left, right, and the back, or 4 fields from either side of slightly anterior and posterior oblique fields. The primary endpoint was the frequency of early AE (≥grade 2) and the secondary endpoint was the biochemical relapse-free survival rate and the frequency of late AE. Results: Forty-five cases were enrolled between 2015 and 2017, and all patients completed the treatment protocol. The median follow-up period was 63.0 months. The frequency of early AE (≥grade 2) was observed in 4 cases (8.9%), therefore the noninferiority was verified. The overall 5-year biochemical relapse-free survival rate was 88.9%. As late AE, grade 2 rectal bleeding was observed in 8 cases (17.8%). Conclusions: The RGPT for prostate cancer with 1.5-mm markers and 3- or 4- fields was as safe as conventional proton therapy in early AE, and its efficacy was comparable with previous studies.
Type: article
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 西岡 健太郎

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