Proseven trial: MR-guided prostate stereotactic body radiotherapy in seven days - First results.

IF 5.3 1区医学 Q1 ONCOLOGY

Radiotherapy and Oncology Pub Date : 2025-10-17 DOI:10.1016/j.radonc.2025.111208

Benjamin Vanspeybroeck, Jacques Bezuidenhout, Guy Soete, Tim Everaert, Anne-Sophie Bom, Jens Van Loon, Sven Van Laere, Thierry Gevaert, Mark De Ridder

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Abstract

Background and purpose: Reducing the overall treatment duration of prostate SBRT has the potential to improve patient comfort and treatment compliance. Additionally, focal boosting to the gross tumor volume (GTV) is of interest to enhance oncologic outcomes. The phase II PROSEVEN trial (MR-guided prostate stereotactic body radiotherapy in seven days) combined both strategies, utilizing MR-guided radiotherapy (MRgRT) to deliver treatment.

Materials and methods: Treatment delivered 36 Gy in five fractions to the planning target volume (PTV), 40 Gy to the clinical target volume (CTV), and up to 42 Gy as a simultaneous integrated boost (SIB) to the intraprostatic tumor (GTV). This was administered using a 0.35-Tesla MR-Linac over a seven-day period. The primary endpoint was the incidence of clinician-reported acute GU and GI toxicity of grade 2 or higher, assessed using CTCAE v5.0. Secondary endpoints included patient-reported outcomes (PROMs). This phase II Proseven trial, approved by the Ethics Committee of UZ Brussels, has completed recruitment with five-year follow-up ongoing.

Results: A total of 132 patients with low (12.1 %), intermediate (66.6 %), and limited high-risk (21.2 %) prostate cancer (Pca) were included. The median PSA at diagnosis was 9.43 ng/ml. SIB to the GTV was performed in 85 % of patients, and 64.4 % completed the treatment within the specified 7 days OTT. No grade 3 acute GU or GI toxicity was observed. Acute Grade 2 GU toxicity occurred in 35 %. Acute Grade 2 GI toxicity occurred in 5 %.

Conclusion: Prostate SBRT with SIB to the GTV in seven days using MRgRT demonstrated acceptable acute GU toxicity rates and low acute GI toxicity.

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Proseven试验：mr引导前列腺立体定向放射治疗7天-初步结果。

背景与目的：缩短前列腺SBRT的总治疗时间有可能改善患者的舒适度和治疗依从性。此外，局部增强肿瘤总体积（GTV）对提高肿瘤预后很有意义。II期PROSEVEN试验（7天内磁共振引导前列腺立体定向放射治疗）结合了这两种策略，利用磁共振引导放射治疗（MRgRT）进行治疗。材料和方法：治疗将36 Gy分五次输送到计划靶体积（PTV）， 40 Gy输送到临床靶体积（CTV），高达42 Gy作为前列腺内肿瘤（GTV）的同步综合增强（SIB）。这是在7天的时间里使用0.35特斯拉的MR-Linac进行的。主要终点是临床报告的2级或以上急性GU和GI毒性的发生率，使用CTCAE v5.0进行评估。次要终点包括患者报告的结局（PROMs）。该II期Proseven试验已获得布鲁塞尔大学伦理委员会批准，已完成招募，并将进行为期五年的随访。结果：共纳入132例低（12.1% %）、中（66.6% %）和有限高危（21.2% %）前列腺癌（Pca）患者。诊断时PSA中位数为9.43 ng/ml。85% %的患者对GTV进行了SIB治疗，64.4 %的患者在规定的7 天内完成了治疗。未观察到3级急性GU或GI毒性。急性2级GU毒性发生率为35% %。急性2级胃肠道毒性发生在5 %。结论：前列腺SBRT伴SIB至GTV 7 d， MRgRT表现出可接受的急性GU毒性率和低急性GI毒性。

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来源期刊

Radiotherapy and Oncology 医学-核医学

CiteScore

10.30

自引率

10.50%

发文量

2445

审稿时长

45 days

期刊介绍： Radiotherapy and Oncology publishes papers describing original research as well as review articles. It covers areas of interest relating to radiation oncology. This includes: clinical radiotherapy, combined modality treatment, translational studies, epidemiological outcomes, imaging, dosimetry, and radiation therapy planning, experimental work in radiobiology, chemobiology, hyperthermia and tumour biology, as well as data science in radiation oncology and physics aspects relevant to oncology.Papers on more general aspects of interest to the radiation oncologist including chemotherapy, surgery and immunology are also published.