The main aim is to assess the impact of using 18F-fluciclovine (as a PET imaging radiotracer) on the clinical and treatment decision required for managing patients with biochemically recurrent prostate cancer (BCR) who are being considered for salvage treatment with the intention of providing disease cure. Also, this study will consolidate the information regarding diagnostic performance of fluciclovine PET/CT in a large number of prospectively followed patients at several centres in the UK and assess the effect of PSA level on the likelihood of detecting cancer lesions by 18F-fluciclovine
Proposed Research In the setting of growing single-centre evidence of superior diagnostic performance of 18F-fluciclovine PET/CT in BCR, our primary aim is to assess its clinical impact on treatment decisions in a multi-centre study in patients with BCR being considered for radical salvage treatment (with curative intent). In addition, we aim to further characterise its diagnostic performance, afforded by larger numbers of patients from multi-centre recruitment. We also aim to assess the effect of PSA level on probability of lesion detection by 18F-fluciclovine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
104
Radioligand for PET CT scanning
Mount Vernon Cancer Centre, Mount Vernon Hospital
Northwood, Middlesex, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
St James Institute of Oncology
Leeds, Yorkshire, United Kingdom
Impact on Patient Treatment /Management
The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.
Time frame: 1 month
Response Rate to Radical Salvage Therapy
To establish the proportion of patients who have a sustained response to radical salvage therapy.
Time frame: 7 months
PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR
PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT
Time frame: 1 month
Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.
Safety was assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection-site status and physical examination findings from the time of administration of 18F fluciclovine injection throughout the study period.
Time frame: 1 month
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Greater Glasgow & Clyde NHS Trust
Glasgow, United Kingdom
University College London Hospital
London, United Kingdom
St Thomas' Hospital
London, United Kingdom