Stereotactic MRI-guided radiation therapy for localized prostate cancer (SMILE): a prospective, multicentric phase-II-trial

作者：Jonas Ristau, Juliane Hörner‐Rieber, Carolin Buchele, Sebastian Klüter, Cornelia Jäkel, Lukas Baumann, Nicolaus Andratschke, Helena Garcia Schüler, Matthias Gückenberger, M Li, Maximilian Niyazi, Claus Belka, Klaus Herfarth, Jürgen Debus, Stefan A. Koerber · 发表于：Radiation Oncology · 年份：2022 · DOI：10.1186/s13014-022-02047-w · 被引用次数：18 · 研究领域：Prostate Cancer Diagnosis and Treatment、Advanced Radiotherapy Techniques、Prostate Cancer Treatment and Research

BACKGROUND: Normofractionated radiation regimes for definitive prostate cancer treatment usually extend over 7-8 weeks. Recently, moderate hypofractionation with doses per fraction between 2.2 and 4 Gy has been shown to be safe and feasible with oncologic non-inferiority compared to normofractionation. Radiobiologic considerations lead to the assumption that prostate cancer might benefit in particular from hypofractionation in terms of tumor control and toxicity. First data related to ultrahypofractionation demonstrate that the overall treatment time can be reduced to 5-7 fractions with single doses > 6 Gy safely, even with simultaneous focal boosting of macroscopic tumor(s). With MR-guided linear accelerators (MR-linacs) entering clinical routine, invasive fiducial implantations become unnecessary. The aim of the multicentric SMILE study is to evaluate the use of MRI-guided stereotactic radiotherapy for localized prostate cancer in 5 fractions regarding safety and feasibility. METHODS: The study is designed as a prospective, one-armed, two-stage, multi-center phase-II-trial with 68 patients planned. Low- and intermediate-risk localized prostate cancer patients will be eligible for the study as well as early high-risk patients (cT3a and/or Gleason Score ≤ 8 and/or PSA ≤ 20 ng/ml) according to d'Amico. All patients will receive definitive MRI-guided stereotactic radiation therapy with a total dose of 37.5 Gy in 5 fractions (single dose 7.5 Gy) on alternating days. A focal simu...