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

Autor: Gary Cook, Manit Arya, Maria Lioumi, Sola Adeleke, Myria Galazi, Hashim U. Ahmed, Harbir S. Sidhu, Jamshed Bomanji, Tony Ng, Simon Chowdhury, Joey Clemente, Manuel Rodriguez-Justo, Athar Haroon, Heather Payne, Manil D Chouhan, Arash Latifoltojar, Steve Morris, Sue Chua, Anthony C. C. Coolen, Taimur T. Shah, Alex Freeman, Reena Davda, Simon Wan, Sachin Vadgama, Shonit Punwani
Přispěvatelé: Morris, Stephen [0000-0002-5828-3563], Apollo - University of Cambridge Repository
Rok vydání: 2019
Předmět:
Male
Cost effectiveness
medicine.medical_treatment
Cost-Benefit Analysis
Brachytherapy
Exosomes
THERAPY
RECOMMENDATIONS
DISEASE
030218 nuclear medicine & medical imaging
Cost comparison
Prostate cancer
Study Protocol
0302 clinical medicine
DESIGN
Recurrence
CRITERIA
Whole Body Imaging
Prospective Studies
Neoplasm Metastasis
Prospective cohort study
medicine.diagnostic_test
Radiology
Nuclear Medicine & Medical Imaging
Magnetic Resonance Imaging
3. Good health
ErbB Receptors
Nuclear Medicine & Medical Imaging
lcsh:R855-855.5
Positron emission tomography
030220 oncology & carcinogenesis
Radiology
Life Sciences & Biomedicine
CLINICAL-TRIALS
MRI
medicine.medical_specialty
lcsh:Medical technology
PET/CT
Sensitivity and Specificity
03 medical and health sciences
Magnetic resonance imaging
TOMOGRAPHY
medicine
Humans
Radiology
Nuclear Medicine and imaging
External beam radiotherapy
Science & Technology
Radiotherapy
business.industry
Prostatic Neoplasms
1103 Clinical Sciences
medicine.disease
Economic evaluation
Radiation therapy
Cost-effectiveness
Neoplasm Recurrence
Local
business
SYSTEM
Zdroj: BMC Medical Imaging
BMC Medical Imaging, Vol 19, Iss 1, Pp 1-11 (2019)
Adeleke, S, Latifoltojar, A, Sidhu, H, Galazi, M, Shah, T T, Clemente, J, Davda, R, Payne, H A, Chouhan, M D, Lioumi, M, Chua, S, Freeman, A, Rodriguez-Justo, M, Coolen, A, Vadgama, S, Morris, S, Cook, G J, Bomanji, J, Arya, M, Chowdhury, S, Wan, S, Haroon, A, Ng, T, Ahmed, H U & Punwani, S 2019, ' 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, vol. 19, no. 1, 90 . https://doi.org/10.1186/s12880-019-0380-y
ISSN: 1471-2342
DOI: 10.1186/s12880-019-0380-y
Popis: 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.
Databáze: OpenAIRE
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