Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
mpMRI/VERDICT
External Beam Radiotherapy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring MRI, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Targeted or Concordant biopsy confirmed prostate cancer
- Pre-biopsy mpMRI scan of the prostate undertaken at University College London Hospital (UCLH)
- Agrees to have ADT and EBRT
Exclusion Criteria:
- Treatment within the previous 6 months with any form of hormones (including 5-alpha reductase inhibitors)
- Evidence of metastatic disease
- Prior local intervention to the prostate
- Unable to give informed consent
- Any prosthesis (including hip replacements) which could cause artefacts degrading the quality of the imaging
- Contraindication to gadolinium contrast agent
- Unable to tolerate an MRI
Sites / Locations
- Urology Research GroupRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pre- and Post- Radiotherapy MRI
Arm 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
Outcomes
Primary Outcome Measures
Measurement of changes in MRI ADC value
Measurement of changes in mpMRI tumour volume (cubic centimetres)
Measurement of changes in enhancement measured as a transfer constant (KTrans) value
Secondary Outcome Measures
Full Information
NCT ID
NCT02721784
First Posted
January 4, 2016
Last Updated
October 25, 2016
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT02721784
Brief Title
Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy
Acronym
SMART
Official Title
Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
MRI, Radiotherapy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre- and Post- Radiotherapy MRI
Arm Type
Other
Arm 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
Intervention Type
Device
Intervention Name(s)
mpMRI/VERDICT
Intervention Description
Combined MRI sequences of T2, DCE, Diffusion and VERDICT
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy
Intervention Description
78Gy (Gray) to Prostate +/- Pelvic
Primary Outcome Measure Information:
Title
Measurement of changes in MRI ADC value
Time Frame
6 months
Title
Measurement of changes in mpMRI tumour volume (cubic centimetres)
Time Frame
6 months
Title
Measurement of changes in enhancement measured as a transfer constant (KTrans) value
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Targeted or Concordant biopsy confirmed prostate cancer
Pre-biopsy mpMRI scan of the prostate undertaken at University College London Hospital (UCLH)
Agrees to have ADT and EBRT
Exclusion Criteria:
Treatment within the previous 6 months with any form of hormones (including 5-alpha reductase inhibitors)
Evidence of metastatic disease
Prior local intervention to the prostate
Unable to give informed consent
Any prosthesis (including hip replacements) which could cause artefacts degrading the quality of the imaging
Contraindication to gadolinium contrast agent
Unable to tolerate an MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taimur T Shah, MBBS,BSc,MRCS
Phone
02076799092
Email
taimur.shah@ucl.ac.uk
Facility Information:
Facility Name
Urology Research Group
City
London
State/Province
England
ZIP/Postal Code
NW1 2PS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taimur T Shah, MBBS,BSc,MRCS
Phone
02076799092
Email
taimur.shah@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Anita Mitra, MBBS MD FRCR
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy
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