Prostate Cancer Clinical Trial
Official title:
Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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