Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer (FALCON)
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|ClinicalTrials.gov Identifier: NCT02578940|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2015
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Prostate||Radiation: Fluciclovine 18 F||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||104 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||May 17, 2017|
|Estimated Study Completion Date :||August 31, 2018|
Experimental: Single arm
Fluciclovine 18F injection (tracer) for PET Scan
Radiation: Fluciclovine 18 F
Radioligand for PET CT scanning
Other Name: FACBC
- Impact on patient treatment /management [ Time Frame: 1 month ]The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.
- Response rate to radical salvage therapy [ Time Frame: 7 months ]To establish the proportion of patients who have a sustained response to radical salvage therapy.
- Diagnostic performance of the fluciclovine (18F) PET/CT scan [ Time Frame: 1 month ]Diagnostic performance will be assessed by analysing sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), using patient and lesion based analyses.
- Effect of PSA levels on detection of recurrent cancer by the fluciclovine (18F) PET/CT scan [ Time Frame: 1 month ]PSA levels in relation to scan positivity will be analysed to determine the optimal PSA threshold for detecting recurrent PCa by fluciclovine (18F) PET/CT.
- Assessment of safety and tolerability [ Time Frame: 1 month ]Safety will be 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 fluciclovine (18F) injection throughout the study period.
- Comparison of detection rates for fluciclovine (18F) PET/CT and choline PET/CT (in the patient subset who receive choline as standard care) [ Time Frame: 1 month ]The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of choline PET will be assessed using patient and lesion based analyses, and compared to that of fluciclovine (18F) PET/CT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578940
|Mount Vernon Cancer Centre, Mount Vernon Hospital|
|Northwood, Middlesex, United Kingdom, HA6 2RN|
|Oxford, Oxfordshire, United Kingdom, OX3 7LE|
|Royal Marsden Hospital|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|St James Institute of Oncology|
|Leeds, Yorkshire, United Kingdom, LS9 7TF|
|Greater Glasgow & Clyde NHS Trust|
|Glasgow, United Kingdom|
|University College London Hospital|
|London, United Kingdom, NW1 2BU|
|St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|Principal Investigator:||Fergus Gleeson, FRCP FRCR||The Oxford University Hospitals NHS Trust|