Prostate Cancer Clinical Trial
— SMARTOfficial title:
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United Kingdom | Urology Research Group | London | England |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
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 |
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