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
{"title":"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）","authors":"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","doi":"10.1186/s13014-025-02653-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov/NCT06834152.</p><p><strong>Protocol version: </strong>Version 6.0.</p>","PeriodicalId":49639,"journal":{"name":"Radiation Oncology","volume":"20 1","pages":"90"},"PeriodicalIF":3.3000,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12117833/pdf/","citationCount":"0","resultStr":"{\"title\":\"Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE).\",\"authors\":\"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\",\"doi\":\"10.1186/s13014-025-02653-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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. 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Online adaptive stereotactic body radiotherapy for localized prostate cancer in patients with lower urinary tract symptoms and/or prostate hyperplasia (X-SMILE).
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.
Radiation OncologyONCOLOGY-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.
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