Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE).

IF 3.3 2区医学 Q2 ONCOLOGY

Radiation Oncology Pub Date : 2025-05-28 DOI:10.1186/s13014-025-02653-4

Tiuri Kroese, Nicolaus Andratschke, Claus Belka, Stefanie Corradini, Sebastian Marschner, Jakob Liermann, Juliane Hörner-Rieber, Christoph Fink, Jürgen Debus, Fabiano Silvia, Stephanie Tanadini-Lang, Bertrand Pouymayou, Alessandro Mencarelli, Debra Fesslmeier, Antonia Schiess, Matthias Guckenberger, Michael Mayinger

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引用次数: 0

Abstract

Background: Stereotactic body radiotherapy (SBRT) for localized prostate cancer offers non-inferior oncological outcomes and toxicity profiles compared to conventionally or moderately hypofractioned radiotherapy regimens, with shorter treatment durations. However, SBRT may not be suitable for all patients, particularly those with lower urogenital tract symptoms and/or prostatic hyperplasia.

Methods: This study aims to evaluate the safety and efficacy of weekly computed tomography (CT) or magnetic resonance image (MRI)-guided online adaptive SBRT in patients with intermediate to high-risk localized prostate cancer (i.e. ≤ cT3a and Gleason score ≤ 9 and PSA ≤ 20 ng/ml) who present with lower urinary tract symptoms (International Prostate Symptom Score [IPSS] > 12) and/or have prostate hyperplasia (prostate volume > 60 mL). The primary outcome measure is urogenital toxicity grade ≥ 3 within 3 months after completion of SBRT (according to CTCAE V5.0) or treatment-related discontinuation. Our aim is to show an event rate of 3% below a clinically acceptable threshold which is set at 20%. Under the null hypothesis, this design with an alpha of 0.05 and power of 80% results in an expected number of cases of 30.

Discussion: In cases of moderate to high IPSS or significant obstructive urodynamics, a pre-emptive transurethral resection of prostate (TURP) may be beneficial. Notably, 10-20% of prostate cancer patients receiving radiotherapy patients have a history of TURP. While TURP can improve obstructive symptoms, its impact on late toxicity, particularly in SBRT, requires further investigation. To mitigate the risk of urogenital toxicity, especially in the case of patients with lower urogenital tract symptoms and/or prostatic hyperplasia, emerging approaches like MR-guided adaptive SBRT and weekly SBRT have shown promise.

Trial registration: ClinicalTrials.gov/NCT06834152.

Protocol version: Version 6.0.

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在线自适应立体定向放射治疗下尿路症状和/或前列腺增生患者的局限性前列腺癌（X-SMILE）

背景：立体定向体放疗（SBRT）治疗局限性前列腺癌，与传统或中度低分割放疗方案相比，具有良好的肿瘤预后和毒性，治疗时间更短。然而，SBRT可能并不适合所有患者，特别是那些有下泌尿生殖道症状和/或前列腺增生的患者。方法：本研究旨在评价中高危局限性前列腺癌患者（即cT3a≤，Gleason评分≤9，PSA≤20 ng/ml）出现下尿路症状（国际前列腺症状评分[IPSS] > 12）和/或前列腺增生（前列腺体积> 60 ml）时，每周CT或MRI引导下在线适应性SBRT的安全性和有效性。主要结局指标是完成SBRT（根据CTCAE V5.0）或治疗相关停药后3个月内的泌尿生殖毒性等级≥3。我们的目标是显示3%的事件发生率低于临床可接受的阈值（设定为20%）。在零假设下，该设计的alpha值为0.05，功率为80%，结果预期病例数为30。讨论：在IPSS中高或明显的尿动力障碍的病例中，先发制人的经尿道前列腺切除术（TURP）可能是有益的。值得注意的是，10-20%接受放疗的前列腺癌患者有TURP病史。虽然TURP可以改善阻塞性症状，但其对晚期毒性的影响，特别是对SBRT的影响，需要进一步研究。为了减轻泌尿生殖系统毒性的风险，特别是在有下泌尿生殖道症状和/或前列腺增生的患者中，诸如mr引导的适应性SBRT和每周SBRT等新兴方法显示出希望。试用注册：ClinicalTrials.gov/NCT06834152.Protocol版本：6.0版本。

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来源期刊

Radiation Oncology ONCOLOGY-RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING

CiteScore

6.50

自引率

2.80%

发文量

181

审稿时长

3-6 weeks

期刊介绍： Radiation Oncology encompasses all aspects of research that impacts on the treatment of cancer using radiation. It publishes findings in molecular and cellular radiation biology, radiation physics, radiation technology, and clinical oncology.