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临床试验/NCT03967080
NCT03967080已完成不适用

Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI) - a Feasibility Study

East and North Hertfordshire NHS Trust1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
Reproducability of DW-MRI

研究概览

简要总结

This small study will investigate the feasibility of using multi-parametric MRI to introduce and support adaptive radiotherapy treatments for high-risk prostate cancer.

详细描述

Mount Vernon Cancer Centre at East and North Hertfordshire NHS Trust offers patients with certain cancers a treatment called adaptive radiotherapy. The aim of adaptive radiotherapy is to respond to physical changes that occur during treatment to ensure the radiation continues to be directed at the cancer and to minimise the amount of healthy tissue treated. For example, if tumour shrinkage or weight loss occurs during head and neck radiotherapy the patient may have a repeat CT scan and a new radiotherapy treatment plan after a few weeks of treatment. For patients with cancer of the bladder or cervix changes in bladder and uterus size and position can be predicted allowing the prospective creation of three radiotherapy treatment plans, each day the best fitting plan, i.e. the one that closely covers the tumour whilst giving minimal dose to normal tissues, is selected and used for treatment, this is known as plan-of-the-day adaptive radiotherapy.

Small changes in shape and position of the prostate occur but are generally the result of rectal changes which cannot be predicted, consequently adaptive radiotherapy based on physical change is not possible for prostate cancer treatments. However, recent literature suggests that magnetic resonance imaging (MRI) can detect changes within the prostate in response to radiotherapy, some studies have seen changes as early as the second week of radiotherapy treatment. A feasibility study to investigate if these changes can support radiotherapy treatment plan adaption for prostate cancer treatments is proposed, whether the plan can be adapted to give a higher treatment dose to any areas of the prostate that show poor response to radiotherapy without increasing bowel and bladder dose is of particular interest. The treatment for patients who participate in the study would not be changed but the results may help to personalise and improve the treatment of future patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • New diagnosis of high-risk prostate cancer: any of:
  • Gleason score of 8, 9 or 10
  • Patient due to receive androgen deprivation therapy (ADT)
  • Prescribed 78Gy/39# external beam radiotherapy
  • Measurable dominant intraprostatic tumour on diagnostic imaging of at least 10mm diameter
  • ≥18 years of age
  • ECOG performance status of 0-1
  • Informed, written and witnessed consent to participate is required.

排除标准

  • Patients who are not due to receive androgen deprivation therapy (ADT)
  • Any contraindication to MRI scanning including contraindication to MRI contrast agents
  • Previous radiotherapy to the pelvis
  • Any physical or social reasons that would make attendance for additional visits impossible.
  • Any patient with or planned for prostate fiducial markers.
  • Unable to give informed consent.
  • Patients currently enrolled in an interventional clinical trial.

结局指标

主要结局

Reproducability of DW-MRI

时间窗: 7 months

Apparent diffusion coefficient (ADC)

MP-MRI Response Correlation

时间窗: 7 months

Developing methods to identify and delineate areas of tumour according to their response to radiotherapy treatment by correlating MP-MRI kinetic parameters with anatomical T2 MRI images

Reproducibility of DCE-MRI

时间窗: 7 months

Using rate constant

Assessment of adapted dosimetry

时间窗: After week 3 of radiotherapy

Amount of acceptable radiotherapeutic dose

次要结局

  • Tumour response prediction(7 months)
  • Assessment of cell kill(3 months)

研究者

发起方
East and North Hertfordshire NHS Trust
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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