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Japanese Journal of Clinical Oncology Advance Access published online on November 28, 2005
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi193
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© 2005 Foundation for Promotion of Cancer Research
Received June 20, 2005
Accepted October 10, 2005

Original Article

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 1 *, Takashi Ogino 1, Satoshi Ishikura 1, Mitsuhiko Kawashima 1, Hideki Nishimura 1, Satoko Arahira 1, and Masakatsu Onozawa 1

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

* To whom correspondence should be addressed.
Keiji Nihei, E-mail: knihei{at}east.ncc.go.jp


  Abstract

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.

Keywords: proton beam therapy; prostate cancer; clinical trial.
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