Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)
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|ClinicalTrials.gov Identifier: NCT02721784|
Recruitment Status : Unknown
Verified October 2016 by University College, London.
Recruitment status was: Recruiting
First Posted : March 29, 2016
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: mpMRI/VERDICT Radiation: External Beam Radiotherapy||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Serial mpMRI (Multi Parametric Magnetic Resonance Imaging) Scanning in Prostate Cancer After Androgen Deprivation Therapy and RadioTherapy (SMART)|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2018|
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
Combined MRI sequences of T2, DCE, Diffusion and VERDICT
Radiation: External Beam Radiotherapy
78Gy (Gray) to Prostate +/- Pelvic
- Measurement of changes in MRI ADC value [ Time Frame: 6 months ]
- Measurement of changes in mpMRI tumour volume (cubic centimetres) [ Time Frame: 6 months ]
- Measurement of changes in enhancement measured as a transfer constant (KTrans) value [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721784
|Contact: Taimur T Shah, MBBS,BSc,MRCSemail@example.com|
|Urology Research Group||Recruiting|
|London, England, United Kingdom, NW1 2PS|
|Contact: Taimur T Shah, MBBS,BSc,MRCS 02076799092 firstname.lastname@example.org|
|Principal Investigator: Anita Mitra, MBBS MD FRCR|