Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer (FALCON)
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ClinicalTrials.gov Identifier: NCT02578940 |
Recruitment Status :
Completed
First Posted : October 19, 2015
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Cancer of the Prostate | Drug: 18F-Fluciclovine PET CT | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | PET Imaging study |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
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 |
Actual Study Completion Date : | June 22, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Single arm
Single intravenous administration of 18F-Fluciclovine for PET Scan
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Drug: 18F-Fluciclovine PET CT
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.
- PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR [ Time Frame: 1 month ]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
- Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT. [ Time Frame: 1 month ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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The subject has had an original diagnosis of PCa and underwent radical curative therapy at least 3 months before enrolment, and has been diagnosed with biochemical recurrence (BCR) on the basis of:
- Post radical radiotherapy (RRT) / brachytherapy: Increase in PSA level ≥2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or
- Post radical prostatectomy (RP): EITHER two consecutive rises in PSA and final PSA >0.1ng/ml OR three consecutive rises in PSA., This definition is also applicable to subjects with PSA persistence post RP (where the PSA fails to fall to undetectable levels).
i. In addition, the subject post RP, should have a PSA doubling time of ≤15 months OR PSA level ≥1.0 ng/mL at time of recruitment. The PSA doubling time will be calculated using the Memorial Sloan Kettering Cancer Center nomogram (http://www.mskcc.org/nomograms/prostate/psa-doubling-time), based on a minimum of two PSA levels within 12 months of screening, taken after the last recorded nadir PSA available at time of screening.
- The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
- The subject is being considered for radical salvage therapy.
- The subject is able and willing to comply with study procedures, and signed, dated and timed informed consent is obtained before any study-related procedure is performed.
- The subject's Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
- The subject should not have received androgen-deprivation therapy within 3 months of screening.
- The subject has a normal or clinically acceptable medical history and vital signs findings at screening (up to 14 days before administration of study drug).
Exclusion Criteria:
- The subject has been previously included in this study.
- The subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before to 1 week after administration of fluciclovine (18F) injection.
- The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.
- The subject has had a choline PET/CT scan within 3 months of the screening visit.
- The subject has bilateral hip prostheses.

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
United Kingdom | |
Mount Vernon Cancer Centre, Mount Vernon Hospital | |
Northwood, Middlesex, United Kingdom, HA6 2RN | |
Churchill Hospital | |
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 |
Documents provided by Blue Earth Diagnostics:
Responsible Party: | Blue Earth Diagnostics |
ClinicalTrials.gov Identifier: | NCT02578940 |
Other Study ID Numbers: |
BED-004 |
First Posted: | October 19, 2015 Key Record Dates |
Results First Posted: | October 7, 2019 |
Last Update Posted: | October 7, 2019 |
Last Verified: | September 2019 |
Prostatic Neoplasms Recurrence Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Prostatic Diseases Disease Attributes Pathologic Processes |