Trial reportRadiation oncology (London, England)2026
Magnetic resonance-guided simultaneous multi-focal adaptive radiotherapy for prostate, pElvis & metastases (MRgSMART-PEM) in prostate cancer: a prospective phase II study.
Trial report in Radiation oncology (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05183074 (Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer
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Authors and funding
15 authors.
Funding
Abstract
purposeTo evaluate the safety, feasibility, and patient-reported outcomes of magnetic resonance-guided simultaneous multi-focal adaptive radiotherapy for the prostate, pelvis, and metastases (MRgSMART-PEM) in patients with high-risk, very-high-risk, or oligometastatic prostate cancer. METHODS AND MATERIALS: In this prospective single-arm phase II study, 35 patients with pathologically confirmed prostate cancer (11 localized, 8 pelvic nodal, 16 oligometastatic) were treated with MRgSMART-PEM on a 1.5-T MR-Linac between June 2021 and March 2025. Radiotherapy was delivered in five alternate-day fractions using an Adapt-to-Shape workflow. The primary endpoint was clinician-reported acute grade ≥ 2 genitourinary (GU) and gastrointestinal (GI) toxicity within 12 weeks. Secondary endpoints included late toxicity, quality of life (QoL), and survival outcomes.
resultsMedian follow-up was 17.2 months (range, 4.3–49.3). The median on-couch time was 59 min (range, 35–80). Acute grade ≥ 2 GU and GI toxicities occurred in 5.7% of patients each, including one grade 3 GI event; all resolved within 8 weeks. No late grade ≥ 2 toxicities were observed, and no grade 1 events persisted beyond 18 months. QoL scores declined at 2 weeks post-treatment but returned to baseline by 3 months. At 2 years, biochemical and clinical progression-free survival rates were both 87.4%, and in-field control was 100%.
conclusionsMRgSMART-PEM is feasible, safe, and well tolerated in patients with high-risk, very-high-risk, and oligometastatic prostate cancer, achieving excellent local control with minimal toxicity and recovery of QoL. These results support further evaluation of MRgSMART-PEM in randomized trials.
trial registrationNCT05183074 (Chinese Academy of Medical Sciences, First Posted 2022-01-10).
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