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Clinical Trials/NCT02721784
NCT02721784
Unknown
Phase 1

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

University College, London1 site in 1 country10 target enrollmentJune 2016
ConditionsProstate Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University College, London
Enrollment
10
Locations
1
Primary Endpoint
Measurement of changes in MRI ADC value
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
January 2018
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Measurement of changes in MRI ADC value

Time Frame: 6 months

Measurement of changes in mpMRI tumour volume (cubic centimetres)

Time Frame: 6 months

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

Time Frame: 6 months

Study Sites (1)

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