Prostate Cancer
Conditions
Keywords
MRI, Radiotherapy
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.
Interventions
DEVICEmpMRI/VERDICT
Combined MRI sequences of T2, DCE, Diffusion and VERDICT
RADIATIONExternal Beam Radiotherapy
78Gy (Gray) to Prostate +/- Pelvic
Sponsors
University College, London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Targeted or Concordant biopsy confirmed prostate cancer 2. Pre-biopsy mpMRI scan of the prostate undertaken at University College London Hospital (UCLH) 3. Agrees to have ADT and EBRT
Exclusion criteria
1. Treatment within the previous 6 months with any form of hormones (including 5-alpha reductase inhibitors) 2. Evidence of metastatic disease 3. Prior local intervention to the prostate 4. Unable to give informed consent 5. Any prosthesis (including hip replacements) which could cause artefacts degrading the quality of the imaging 6. Contraindication to gadolinium contrast agent 7. Unable to tolerate an MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of changes in MRI ADC value | 6 months |
| Measurement of changes in mpMRI tumour volume (cubic centimetres) | 6 months |
| Measurement of changes in enhancement measured as a transfer constant (KTrans) value | 6 months |
Countries
United Kingdom
Contacts
Primary ContactTaimur T Shah, MBBS,BSc,MRCS
Outcome results
None listed