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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: mpMRI/VERDICT; Radiation: External Beam Radiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, NW1 2PS
      • Recruiting
      • Urology Research Group
      • Contact: Taimur T Shah, MBBS,BSc,MRCS; Phone Number: 02076799092; Email: taimur.shah@ucl.ac.uk
      • Principal Investigator: Anita Mitra, MBBS MD FRCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pre- and Post- Radiotherapy MRI; 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	Device: mpMRI/VERDICT; Combined MRI sequences of T2, DCE, Diffusion and VERDICT; Radiation: External Beam Radiotherapy; 78Gy (Gray) to Prostate +/- Pelvic

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: MRI; Radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 15/0342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED