Clinical trial NCT02721784: Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy
Official title: Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: MRI
Radiotherapy
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of changes in MRI ADC value
timeFrame: 6 months
measure: Measurement of changes in mpMRI tumour volume (cubic centimetres)
timeFrame: 6 months
measure: Measurement of changes in enhancement measured as a transfer constant (KTrans) value
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Urology Research Group
state: England
Study officials:
References: