Prospective Clinical Study Comparing PROMS After Adaptive or Conventional Radiotherapy in Prostate Cancer

Официальное название

Prospective Clinical Study Comparing Patient-reported Outcomes Measurements (PROMS) After Adaptive or Conventional Radiotherapy in Prostate Cancer

Обзор

This prospective clinical study compares patient-reported outcome measures (PROMs) after adaptive or conventional radiotherapy in prostate cancer. Adaptive radiotherapy (ART) aims to reduce uncertainties related to daily anatomical variations, thereby improving treatment accuracy while decreasing gastrointestinal (GI) and genitourinary (GU) toxicity. This study, conducted at Cliniques universitaires Saint-Luc (Brussels and Ottignies sites), analyzes and compares toxicities in patients treated with ART on Ethos and those treated with conventional radiotherapy on Halcyon. The primary objective of the study is to demonstrate that ART reduces gastrointestinal, urinary, and general side effects induced by radiotherapy. Additionally, the secondary objectives include assessing the duration of these effects, correlating them with dosimetric data, analyzing the management of toxicities through the Noona e-health application, as well as evaluating the use of this application by both patients and healthcare providers. The study includes men aged 18 years or older with prostate cancer undergoing curative-intent treatment, with an ECOG performance status of 0 to 1, and able to use the Noona application. Patients with a history of rectal or bladder treatment, or those who have already received pelvic radiotherapy, are excluded. Two groups are compared: patients treated with conventional radiotherapy on Halcyon (Ottignies site) and those treated with adaptive radiotherapy on Ethos (Brussels site).

Вмешательства

• Лучевая терапия Radiotherapy
  Prostate cancer patients will be treated radiotherapy.

Первичные конечные точки

• Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires. [Срок оценки: 3 years]

Вторичные конечные точки (4)

• Evaluation of the time to recovery from treatment-related adverse effects using PROMS questionnaires. [Срок оценки: 3 years]
• Correlation of the duration of adverse effects collected with PROMS questionnaire with the dosimetric data. [Срок оценки: 3 years]
• Evaluation of the management of treatment-related toxicity using the e-health application using a PREM questionnaire at the end of the study. [Срок оценки: 3 years]
• Number of participants and medical staff satisfied by the ease of use of an e-health application during radiotherapy using a questionnaire. [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Patients with prostate cancer referred for curative-intent radiotherapy
• Male patients ≥ 18 years old
• ECOG performance status 0-1
• Patients willing to use an e-health application
• Patients capable of using an e-health application
• Proficient in French, English, or Dutch
• No prior history of treatment for rectal or bladder cancer
• No prior history of pelvic radiotherapy

Критерии исключения

• Cognitive impairment
• ECOG ≥ 2
• History of treatment for rectal or bladder cancer
• History of pelvic radiotherapy
• No access to the Noona application on a smartphone or computer

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Cliniques universitaires Saint-Luc — Brussels

Публикации

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• Heemsbergen WD, Hoogeman MS, Witte MG, Peeters ST, Incrocci L, Lebesque JV. Increased risk of biochemical and clinical failure for prostate patients with a large rectum at radiotherapy planning: results from the Dutch trial of 68 GY versus 78 Gy. Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1418-24. doi: 10.1016/j.ijrobp.2006.11.014. Epub 2007 Jan 22. PMID 17241751
• Yan D, Vicini F, Wong J, Martinez A. Adaptive radiation therapy. Phys Med Biol. 1997 Jan;42(1):123-32. doi: 10.1088/0031-9155/42/1/008. PMID 9015813
• Posiewnik M, Piotrowski T. A review of cone-beam CT applications for adaptive radiotherapy of prostate cancer. Phys Med. 2019 Mar;59:13-21. doi: 10.1016/j.ejmp.2019.02.014. Epub 2019 Feb 22. PMID 30928061
• Byrne M, Archibald-Heeren B, Hu Y, Teh A, Beserminji R, Cai E, Liu G, Yates A, Rijken J, Collett N, Aland T. Varian ethos online adaptive radiotherapy for prostate cancer: Early results of contouring accuracy, treatment plan quality, and treatment time. J Appl Clin Med Phys. 2022 Jan;23(1):e13479. doi: 10.1002/acm2.13479. Epub 2021 Nov 29. PMID 34846098
• Thornqvist S, Hysing LB, Tuomikoski L, Vestergaard A, Tanderup K, Muren LP, Heijmen BJ. Adaptive radiotherapy strategies for pelvic tumors - a systematic review of clinical implementations. Acta Oncol. 2016 Aug;55(8):943-58. doi: 10.3109/0284186X.2016.1156738. Epub 2016 Apr 8. PMID 27055486
• Christiansen RL, Dysager L, Hansen CR, Jensen HR, Schytte T, Nyborg CJ, Bertelsen AS, Agergaard SN, Mahmood F, Hansen S, Hansen O, Brink C, Bernchou U. Online adaptive radiotherapy potentially reduces toxicity for high-risk prostate cancer treatment. Radiother Oncol. 2022 Feb;167:165-171. doi: 10.1016/j.radonc.2021.12.013. Epub 2021 Dec 16. PMID 34923034
• Brunelli C, Zito E, Alfieri S, Borreani C, Roli A, Caraceni A, Apolone G. Knowledge, use and attitudes of healthcare professionals towards patient-reported outcome measures (PROMs) at a comprehensive cancer center. BMC Cancer. 2022 Feb 10;22(1):161. doi: 10.1186/s12885-022-09269-x. PMID 35144569

Идентификаторы

NCT: NCT07245745 · 2025/27MAI/209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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