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

NCT02721784 | Unknown Phase 1 DMC

• 1 other identifier: 15/0342
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

MRI; Radiotherapy

Outcome Measures

Primary Outcomes (3)

• Measurement of changes in MRI ADC value

  6 months

• Measurement of changes in mpMRI tumour volume (cubic centimetres)

  6 months

• Measurement of changes in enhancement measured as a transfer constant (KTrans) value

  6 months

Study Arms (1)

Pre- and Post- Radiotherapy MRI

OTHER

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

Device: mpMRI/VERDICT; Radiation: External Beam Radiotherapy

Interventions

mpMRI/VERDICT DEVICE

Combined MRI sequences of T2, DCE, Diffusion and VERDICT

Pre- and Post- Radiotherapy MRI

External Beam Radiotherapy RADIATION

78Gy (Gray) to Prostate +/- Pelvic

Pre- and Post- Radiotherapy MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Urology Research Group

London, England, NW1 2PS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Taimur T Shah, MBBS,BSc,MRCS

CONTACT

02076799092; taimur.shah@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: March 29, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

GB (1)