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Japanese Journal of Clinical Oncology Advance Access originally published online on November 28, 2005
Japanese Journal of Clinical Oncology 2005 35(12):745-752; doi:10.1093/jjco/hyi193
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© 2005 Foundation for Promotion of Cancer Research

Phase II Feasibility Study of High-Dose Radiotherapy for Prostate Cancer Using Proton Boost Therapy: First Clinical Trial of Proton Beam Therapy for Prostate Cancer in Japan

Keiji Nihei, Takashi Ogino, Satoshi Ishikura, Mitsuhiko Kawashima, Hideki Nishimura, Satoko Arahira and Masakatsu Onozawa

Radiation Oncology Division, National Cancer Center Hospital East, Kashiwa, Chiba, Japan

For reprints and all correspondence: Keiji Nihei, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: knihei{at}east.ncc.go.jp

Received June 20, 2005; accepted October 10, 2005

Objective: To assess the feasibility of high-dose radiotherapy for prostate cancer using proton boost therapy following photon radiotherapy.

Methods: The primary endpoint was acute grade 3 or greater genitourinary (GU) and gastrointestinal (GI) toxicities. The study included patients with clinical stage T1-3N0M0 prostate cancer. Radiotherapy consisted of 50 Gy/25 fx photon irradiation to the prostate and the bilateral seminal vesicles followed by proton boost of 26 GyE/13 fx to the prostate alone. Hormonal therapy was allowed before and during the radiation therapy.

Results: Between January 2001 and January 2003, 30 patients were enrolled in this study. Acute grade 1/2 GU and GI toxicities were observed in 20/4 and 17/0 patients, respectively. With the median follow-up period of 30 months (range 20–45), late grade 1/2 GU and GI toxicities occurred in 2/3 and 8/3 patients, respectively. No grade 3 or greater acute or late toxicities were observed. All patients were alive, but six patients relapsed biochemically after 7–24 months.

Conclusions: Proton boost therapy following photon radiotherapy for prostate cancer is feasible. To evaluate the efficacy and safety of proton beam therapy, a multi-institutional phase II trial is in progress in Japan.

Key Words: proton beam therapy • prostate cancer • clinical trial


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