Prostate Adaptive Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- Age > 18
- •Biopsy proven prostate malignancy
- •Definitive treatment is radiotherapy to the prostate alone
- •ECOG performance status 0-2
- •Ability to understand and the willingness to sign an informed consent
排除标准
- •Hip prosthesis
- •Patient separation from prostate centre to skin edge > 24cm, measured on diagnostic scan-
研究组 & 干预措施
Adaptive radiotherapy +/- margin reduction
Phase 1 and 2: Treating Radiation Therapists (RTs) on the treatment machine will review the treatment target and organs at risk contours that are automatically generated on the plan of the day. They will modify these safely, as required, and then also approve the computer generated re-plan of the day, within the bounds of departmental protocols and decision guides (RT led).
Phase 2 only: Margin reduction facilitated by adaptive radiotherapy.
干预措施: Adaptive radiotherapy +/- Margin Reduction (Radiation)
Standard radiotherapy
Patients will receive standard image guided radiotherapy
干预措施: Image guided radiotherapy (Radiation)
结局指标
主要结局
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage)
时间窗: 12 months
A comparison of Clinical Target Volume (CTV) dose coverage will be performed. The CTV dose coverage must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction. Dose coverage will be calculated as the percent of CTV receiving at least 95% of the prescribed dose (TD).
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints)
时间窗: 12 months
A comparison of organ at risk (OAR) dose-volume histogram (DVH) constraints will be performed. The OAR DVH dose constraints must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction.
Feasibility of ART via RT-led* treatment delivery
时间窗: 12 months
At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.
Acute patient reported toxicity
时间窗: Within 90 days of patients completing treatment
The study will measure the difference in patient reported combined maximum GU and GI toxicity (Grade 2 or higher) as per PRO-CTCAE between the two treatment arms.
次要结局
- Late patient reported toxicity(5 years)
- Time differences between treatment arms(1 and 5 years)
- Acute clinician reported toxicity(Within 90 days of patients completing treatment)
- Late clinician reported toxicity(5 years)
- Biochemical progression Free Survival(3 and 5 years)
- Radiation dosimetric differences between treatment arms(1 and 5 years)
- Patient reported attitudes and perceptions(1 and 5 years)