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Brief Title: Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer
Official Title: A Phase 3, Open-label Study to Assess the Clinical Utility of Fluciclovine (18F) PET/CT in Patients With Prostate Cancer With Biochemical Recurrence After Radical Treatment
Study ID: NCT02578940
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Greater Glasgow & Clyde NHS Trust, Glasgow, , United Kingdom
University College London Hospital, London, , United Kingdom
St Thomas' Hospital, London, , United Kingdom
Name: Fergus Gleeson, FRCP FRCR
Affiliation: The Oxford University Hospitals NHS Trust
Role: PRINCIPAL_INVESTIGATOR