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

University College London (UCL)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: External Beam Radiotherapy; Device: mpMRI/VERDICT

Study type: Interventional

Funder types: Other

Identifiers

NCT02721784

15/0342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pre- and Post- Radiotherapy MRI

Other group

Description:

mpMRI/VERDICT sequences to be preformed pre- and post- EBRT (external beam radiotherapy) according to the following schedule: Pre-Androgen Deprivation Therapy 3 weeks before radiotherapy 6 week after starting radiotherapy 6 Months after starting radiotherapy External Beam Radiotherapy to be given after 3 months of androgen deprivation

Treatment:

Radiation: External Beam Radiotherapy

Device: mpMRI/VERDICT