Localising occult prostate cancer metastasis with advanced imaging techniques (LOCATE trial): a prospective cohort, observational diagnostic accuracy trial investigating whole–body magnetic resonance imaging in radio-recurrent prostate cancer

BMC Medical Imaging

Manil D. Chouhan¹  Sola Adeleke¹  Harbir Sidhu¹  Arash Latifoltojar¹  Joey Clemente¹  Shonit Punwani¹  Maria Lioumi²  Steve Morris³  Sachin Vadgama³  Gary J. Cook⁴  Athar Haroon⁵  Sue Chua⁶  Taimur T. Shah⁷  Hashim Uddin Ahmed⁸  Alex Freeman⁹  Manuel Rodriguez-Justo⁹  Anthony Coolen^1,10  Simon Wan^1,11  Jamshed Bomanji^1,11  Myria Galazi^1,12  Tony Ng^1,12  Simon Chowdhury^1,13  Reena Davda^1,14  Heather Ann Payne^1,14  Manit Arya^1,15 

[1] Centre for Medical Imaging, University College London;Comprehensive Cancer Imaging Centre (CCIC), King’s College, London, New Hunt’s House;Department of Applied Health Research, University College London;Department of Cancer Imaging, School of Biomedical Engineering and Imaging Sciences, King’s College London;Department of Nuclear Medicine, St Bartholomew’s Hospital;Department of Nuclear Medicine, The Royal Marsden Hospital NHS Foundation Trust;Division of Surgery and Interventional Science, University College London;Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London;Histopathology Department, University College London Hospital;Institute for Mathematical and Molecular Biomedicine, King’s College London;Institute of Nuclear Medicine, University College London Hospital;Molecular Oncology Group, University College London, Cancer Institute;Oncology Department, Guy’s and St. Thomas’ Hospital;Oncology Department, University College London Hospital;Urology Department, University College Hospital;

关键词: Magnetic resonance imaging;    Prostate cancer;    Radiotherapy;    Brachytherapy;    Recurrence;    Positron emission tomography;   

DOI  :  10.1186/s12880-019-0380-y

来源: DOAJ

【 摘 要 】

Abstract Background Accurate whole-body staging following biochemical relapse in prostate cancer is vital in determining the optimum disease management. Current imaging guidelines recommend various imaging platforms such as computed tomography (CT), Technetium 99 m (99mTc) bone scan and 18F-choline and recently 68Ga-PSMA positron emission tomography (PET) for the evaluation of the extent of disease. Such approach requires multiple hospital attendances and can be time and resource intensive. Recently, whole-body magnetic resonance imaging (WB-MRI) has been used in a single visit scanning session for several malignancies, including prostate cancer, with promising results, providing similar accuracy compared to the combined conventional imaging techniques. The LOCATE trial aims to investigate the application of WB-MRI for re-staging of patients with biochemical relapse (BCR) following external beam radiotherapy and brachytherapy in patients with prostate cancer. Methods/design The LOCATE trial is a prospective cohort, multi-centre, non-randomised, diagnostic accuracy study comparing WB-MRI and conventional imaging. Eligible patients will undergo WB-MRI in addition to conventional imaging investigations at the time of BCR and will be asked to attend a second WB-MRI exam, 12-months following the initial scan. WB-MRI results will be compared to an enhanced reference standard comprising all the initial, follow-up imaging and non-imaging investigations. The diagnostic performance (sensitivity and specificity analysis) of WB-MRI for re-staging of BCR will be investigated against the enhanced reference standard on a per-patient basis. An economic analysis of WB-MRI compared to conventional imaging pathways will be performed to inform the cost-effectiveness of the WB-MRI imaging pathway. Additionally, an exploratory sub-study will be performed on blood samples and exosome-derived human epidermal growth factor receptor (HER) dimer measurements will be taken to investigate its significance in this cohort. Discussion The LOCATE trial will compare WB-MRI versus the conventional imaging pathway including its cost-effectiveness, therefore informing the most accurate and efficient imaging pathway. Trial registration LOCATE trial was registered on ClinicalTrial.gov on 18th of October 2016 with registration reference number NCT02935816.

【 授权许可】

Unknown