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Trial record 61 of 1543 for:    Androgens

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: mpMRI/VERDICT Radiation: External Beam Radiotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Measurement of changes in MRI ADC value [ Time Frame: 6 months ]
  2. Measurement of changes in mpMRI tumour volume (cubic centimetres) [ Time Frame: 6 months ]
  3. Measurement of changes in enhancement measured as a transfer constant (KTrans) value [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02721784

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Contact: Taimur T Shah, MBBS,BSc,MRCS 02076799092

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United Kingdom
Urology Research Group Recruiting
London, England, United Kingdom, NW1 2PS
Contact: Taimur T Shah, MBBS,BSc,MRCS    02076799092   
Principal Investigator: Anita Mitra, MBBS MD FRCR         
Sponsors and Collaborators
University College, London

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Responsible Party: University College, London Identifier: NCT02721784     History of Changes
Other Study ID Numbers: 15/0342
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University College, London:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs