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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

Tracking Information
First Submitted Date  ICMJE October 15, 2015
First Posted Date  ICMJE October 19, 2015
Results First Submitted Date  ICMJE August 9, 2019
Results First Posted Date  ICMJE October 7, 2019
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date May 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2015)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
PET Imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cancer of the Prostate
Intervention  ICMJE Drug: 18F-Fluciclovine PET CT
Radioligand for PET CT scanning
Other Name: FACBC
Study Arms  ICMJE Experimental: Single arm
Single intravenous administration of 18F-Fluciclovine for PET Scan
Intervention: Drug: 18F-Fluciclovine PET CT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
104
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2015)
180
Actual Study Completion Date  ICMJE June 22, 2018
Actual Primary Completion Date May 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02578940
Other Study ID Numbers  ICMJE BED-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Blue Earth Diagnostics
Study Sponsor  ICMJE Blue Earth Diagnostics
Collaborators  ICMJE
  • Innovate UK
  • Syne Qua Non Limited
  • IND 2 Results LLC
Investigators  ICMJE
Principal Investigator: Fergus Gleeson, FRCP FRCR The Oxford University Hospitals NHS Trust
PRS Account Blue Earth Diagnostics
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP