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

Prostate Cancer Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721784
• Other study ID #: 15/0342
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 4, 2016
• Last updated: October 25, 2016
• Start date: June 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: University College, London
• Contact: Taimur T Shah, MBBS,BSc,MRCS
• Phone: 02076799092
• Email: taimur.shah[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• mpMRI/VERDICT
Combined MRI sequences of T2, DCE, Diffusion and VERDICT

Radiation:
• External Beam Radiotherapy
78Gy (Gray) to Prostate +/- Pelvic

Locations

Country	Name	City	State
United Kingdom	Urology Research Group	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of changes in MRI ADC value		6 months	No
Primary	Measurement of changes in mpMRI tumour volume (cubic centimetres)		6 months	No
Primary	Measurement of changes in enhancement measured as a transfer constant (KTrans) value		6 months	No