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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
Sponsor:
Collaborators:
Innovate UK
Syne Qua Non Limited
IND 2 Results LLC
Information provided by (Responsible Party):
Blue Earth Diagnostics

Study Description
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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

Condition or disease Intervention/treatment Phase
Cancer of the Prostate Drug: 18F-Fluciclovine PET CT Phase 3

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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
Single intravenous administration of 18F-Fluciclovine for PET Scan
 Drug: 18F-Fluciclovine PET CT
Radioligand for PET CT scanning
Other Name: FACBC


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. 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
    2. 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.
Contacts and Locations
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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


Locations
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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
Sponsors and Collaborators
Blue Earth Diagnostics
Innovate UK
Syne Qua Non Limited
IND 2 Results LLC
Investigators
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Principal Investigator: Fergus Gleeson, FRCP FRCR The Oxford University Hospitals NHS Trust
  Study Documents (Full-Text)

Documents provided by Blue Earth Diagnostics:
Study Protocol  [PDF] June 4, 2018
Statistical Analysis Plan  [PDF] October 10, 2018

More Information
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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes