Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy
NCT ID: NCT02721784
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2016-06-30
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
mpMRI/VERDICT
Combined MRI sequences of T2, DCE, Diffusion and VERDICT
External Beam Radiotherapy
78Gy (Gray) to Prostate +/- Pelvic
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mpMRI/VERDICT
Combined MRI sequences of T2, DCE, Diffusion and VERDICT
External Beam Radiotherapy
78Gy (Gray) to Prostate +/- Pelvic
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Pre-biopsy mpMRI scan of the prostate undertaken at University College London Hospital (UCLH)
3. Agrees to have ADT and EBRT
Exclusion Criteria
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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Urology Research Group
London, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Taimur T Shah, MBBS,BSc,MRCS
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15/0342
Identifier Type: -
Identifier Source: org_study_id