Protocol summary of a randomized controlled phase III trial for confirming the superiority of local radiotherapy for prostate cancer patients with high-volume metastasis sensitive to hormonal therapy: the JCOG2011 (HimeRT study)
Local therapy is not considered a standard treatment option for patients with high-volume metastatic prostate cancer. Our research group's previous retrospective study indicated potential benefits of local radiotherapy (LRT) for some high-volume metastatic prostate cancer patients, but prospective studies have yet to confirm these findings. We have thus planned a multicenter, open-label, randomized controlled phase III trial to confirm the efficacy of adding LRT to systemic hormonal therapy with androgen deprivation therapy plus an androgen receptor pathway inhibitor in a population of high-volume metastatic prostate cancer patients for whom the hormonal therapy is effective for 6 months. The primary endpoint is failure-free survival, defined as the time from randomization to prostate-specific antigen progression, radiological progression, clinical progression, or death from any cause. We aim to enroll 360 patients from 56 institutions over a 4-year period. This trial is registered at the Japan Registry of Clinical Trials (study no. jRCT1031220676).
Authors
- Keita Sasaki (ORCID: https://orcid.org/0009-0005-5100-3863)
- Taro Shibata
- Masaki Shiota (ORCID: https://orcid.org/0000-0002-3306-4858)
- Takashi Mizowaki (ORCID: https://orcid.org/0000-0002-8135-8746)
- Rihito Aizawa (ORCID: https://orcid.org/0000-0001-7098-6221)
- Keiji Nihei (ORCID: https://orcid.org/0000-0002-9603-0567)
- Takahiro Kojima (ORCID: https://orcid.org/0000-0003-4150-9631)
- Shintaro Narita (ORCID: https://orcid.org/0000-0003-2988-1860)
- Takahiro Inoue (ORCID: https://orcid.org/0000-0001-8586-784X)
- Hiroyuki Nishiyama (ORCID: https://orcid.org/0000-0001-7423-596X)
- Mikio Sugimoto (ORCID: https://orcid.org/0000-0001-9266-782X)
- Takahiro Kimura (ORCID: https://orcid.org/0000-0002-5673-1553)
- Shusuke Akamatsu (ORCID: https://orcid.org/0000-0002-1394-7506)
- Naoki Terada (ORCID: https://orcid.org/0009-0005-1082-6089)
- Yuta Sekino (ORCID: https://orcid.org/0000-0001-8885-4972)
- Hiroshi Kitamura (ORCID: https://orcid.org/0000-0002-1592-931X)
- Haruhiko Fukuda
Institutions
- Jikei University School of Medicine (JP)
- Kyushu University (JP)
- Mie University (JP)
- Kagawa University (JP)
- Akita University (JP)
- Kyoto University (JP)
- Takamatsu University (JP)
- Nagoya University Hospital (JP)
- Kyushu University Hospital (JP)
- University of Fukui Hospital (JP)
- University of Tsukuba Hospital (JP)
- Aichi Cancer Center (JP)
- Japan Clinical Cancer Research Organization (JP)
- University of Toyama (JP)
- Nagoya University (JP)
- Osaka University of Pharmaceutical Sciences (JP)
Publication Details
- Journal
- Japanese Journal of Clinical Oncology
- Published
- 2025-09-26
- DOI
- https://doi.org/10.1093/jjco/hyaf157
- Primary Topic
- Prostate Cancer Treatment and Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00