跳至主要内容
临床试验/NCT02721784
NCT02721784Unknown1 期

Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)

University College, London2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
1 期
入组人数
10
试验地点
2
主要终点
Measurement of changes in MRI ADC value

研究概览

简要总结

The evaluation of the radiological changes in localised or locally advanced prostate cancer after androgen deprivation therapy and external beam radiotherapy using multi-parametric MRI (multi parametric magnetic resonance imaging) and VERDICT (Vascular, Extracellular and Restricted Diffusion for Cytometry in Tumours) sequences.

详细描述

External beam radiotherapy (EBRT) fails to eradicate prostate cancer in 24-33% of cases. Response is monitored solely by testing serum prostate specific antigen (PSA), with biochemical failure following radiotherapy defined as a prostate specific antigen (PSA) level of 2 ng/ml above the nadir.

T2 and Dynamic Contrast Enhanced (DCE) MRI have been shown to be able to detect the recurrence of prostate cancer following radiotherapy. Changes seen in Apparent Diffusion Coefficient (ADC) variables post-treatment have potential use in monitoring disease response to radiotherapy but the natural history of these changes during and after treatment remains uncertain and warrants further investigation.

This study investigates the feasibility of using multi-parametric MRI (mpMRI) and novel diffusion-weighted sequences called VERDICT (Vascular, Extracellular and Restricted Diffusion for Cytometry in Tumours) at various stages during the treatment of prostate cancer with radiotherapy. Patients will be first scanned before androgen deprivation therapy (ADT) starts, then 3 weeks before the start of radiotherapy, again in week 6 of radiotherapy and once more 6 months after the end of radiotherapy. In addition, all patients entered into the study will already have had a mpMRI scan prior to prostate biopsy as part of their standard care.

Multi-parametric MRI and VERDICT sequences may reveal changes in the tumour and normal prostate before a detectable PSA increase. This could allow for their use in response assessment following radiotherapy and androgen deprivation treatment. If such clinical utility is proven, referral for salvage treatment using High Intensity Focussed Ultrasound (HIFU), cryotherapy or salvage radical prostatectomy may be expedited.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Targeted or Concordant biopsy confirmed prostate cancer
  • Pre-biopsy mpMRI scan of the prostate undertaken at University College London Hospital (UCLH)
  • Agrees to have ADT and EBRT

排除标准

  • Treatment within the previous 6 months with any form of hormones (including 5-alpha reductase inhibitors)
  • Evidence of metastatic disease
  • Prior local intervention to the prostate
  • Unable to give informed consent
  • Any prosthesis (including hip replacements) which could cause artefacts degrading the quality of the imaging
  • Contraindication to gadolinium contrast agent
  • Unable to tolerate an MRI

结局指标

主要结局

Measurement of changes in MRI ADC value

时间窗: 6 months

Measurement of changes in mpMRI tumour volume (cubic centimetres)

时间窗: 6 months

Measurement of changes in enhancement measured as a transfer constant (KTrans) value

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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