Serial mpMRI scanning in prostate cancer post ADT and RT
Research type
Research Study
Full title
Serial mpMRI scanning in prostate cancer after Androgen deprivation therapy and RadioTherapy (SMART)
IRAS ID
178804
Contact name
Anita Vanessa Mitra
Contact email
Sponsor organisation
University College London sponsor representative and database and information officer
Clinicaltrials.gov Identifier
15/0342, R&D Number
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
External beam radiotherapy (EBRT) fails to eradicate prostate cancer in 24-33% of cases. Response is monitored solely by a prostate specific antigen (PSA) blood test. Failure following radiotherapy has been defined as a PSA level of 2 ng/ml above the lowest value/nadir.
MRI with the addition of contrast/dye injected into the patient hass been shown to be able to detect the recurrence of prostate cancer fllowing radiotherapy. Changes seen in MRI (diffusion) variables/sequences after treatment has 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 all these so-called “multi-parametric” MRI (mpMRI) sequences and an additional novel sequence called VERDICT (Vascular, Extracellular and Restricted Diffusion for Cytometry in Tumours) at various stages during the treatment of prostate cancer with radiotherapy.
Hormonal treatment, also called androgen deprivation therapy (ADT), has been shown to increase the effectiveness of radiotherapy but this can it self cause changes within the prostate. Thus patients will be first scanned before they start ADT, 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 any prostate biopsy that may be needed as part of their standard care.
Once patients fail radiotherapy they can be offered additional treatments called “salvage” therapy. Multi-parametric MRI and VERDICT sequences may reveal changes in the cancer and normal prostate before a detectable PSA increase. This could allow for their use in response assessment following radiotherapy and ADT. If such clinical utility is proven, referral for salvage treatment using high intesisty focused ultrasound (HIFU, heating) or cryotherapy (freezing) or salvage surgery (radical prostatectomy) may be expedited.
REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/1845
Date of REC Opinion
27 Nov 2015
REC opinion
Favourable Opinion