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Набира участници Не е приложимо NCT06547398

Prostate Adaptive Radiation Therapy

Не е приложима фаза (напр. обсервационно)
Заболявания: Prostatic Neoplasms

Спонсор: Royal North Shore Hospital

Налично на: БГ
Обобщение
Prostate ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for prostate cancer patients. Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced. Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2. Part 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for prostate cancer patients.
Описание
Despite major technological advancements in the delivery of pelvic radiation therapy including the use of dynamic therapy, image guidance, integrated boosting and stereotactic techniques, toxicity from pelvic radiation remains a significant issue impacting on patient's quality of life and preventing the delivery of higher (and more curative) doses of radiation. Although evidence showed that adaptive radiotherapy demonstrating promising reduction of acute toxicity, the uptake of adaptive radiotherapy remains poor as adaptive radiation therapy is very labour intensive, time consuming and usually requires a radiation oncologist (RO) and Medical Physicist in attendance to review/modify target contours. These practices of daily multi-disciplinary team (MDT) in person attendance is not sustainable in the long term. Since 2021, Royal North Shore Hospital has been treating patients with cancer in the pelvic with Adaptive Radiation Therapy (ART) and Radiation Therapists (RT) at the site have undergone a rigorous University based Advanced Practitioner training programme. This study aims to evaluate RT-led ART in a randomised trial to assess the safety and feasibility of ART in a two stage phase 3 randomised controlled trial. If this study can prove safety and feasibility in the first phase, it will proceed to the second phase of the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV margins. The primary aim of the study will be to measure the difference in combined acute patient reported gastrointestinal (GI) and genitourinary (GU) toxicity between ART with margin reduction versus standard radiotherapy. Secondary aims will be to look at differences in biochemical failure, the time efficiency of ART, the radiation dosimetric differences between the treatment arms and patients' perception of ART.
Кой може да участва
Inclusion Criteria: 1. \- Age \> 18 2. Biopsy proven prostate malignancy 3. Definitive treatment is radiotherapy to the prostate alone 4. ECOG performance status 0-2 5. Ability to understand and the willingness to sign an informed consent Exclusion Criteria: 1. Hip prosthesis 2. Patient separation from prostate centre to skin edge \> 24cm, measured on diagnostic scan-
Места на провеждане 1
Австралия (1)
Northern Sydney Cancer Centre, Royal North Shore Hospital
St Leonards , New South Wales
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.10.2025
Крайна дата
31.10.2031
Регистрационен номер
NCT06547398
Източник
anzctr
Запитване за медицински туризъм

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