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    Summary
    EudraCT Number:2015-000625-37
    Sponsor's Protocol Code Number:BED-004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-000625-37
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the usefulness of fluciclovine (18F) PET/CT in patients with rising PSA after treatment of prostate cancer
    A.3.2Name or abbreviated title of the trial where available
    FALCON (Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of prostate cancer)
    A.4.1Sponsor's protocol code numberBED-004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBlue Earth Diagnostics Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnovate UK (Technology Strategy Board)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBlue Earth Diagnostics Limited
    B.5.2Functional name of contact pointBlue Earth Diagnostics Limited
    B.5.3 Address:
    B.5.3.1Street AddressThe Oxford Science Park, Magdalen Centre, Robert Robinson Avenue
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX4 4GA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441865784186
    B.5.5Fax number441865784189
    B.5.6E-mailcontact@blueearthDx.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluciclovine (18F) injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer with biochemical recurrence after radical treatment
    E.1.1.1Medical condition in easily understood language
    Recurrent prostate cancer
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical impact of fluciclovine (18F) PET/CT in affecting management decisions in patients with biochemical recurrence of prostate cancer (BCR) being considered for radical salvage treatment (with curative intent).
    E.2.2Secondary objectives of the trial
    1. To assess possible improvement in outcome of radical salvage treatment based on fluciclovine (18F) PET/CT being included in the assessment.
    2. To assess the prostate specific antigen (PSA) threshold for positive lesion detection by fluciclovine (18F) PET/CT in BCR.
    3. To assess the safety of fluciclovine (18F) injection in patients undergoing PET/CT.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Evaluation and optimisation of Bayesian penalised likelihood PET reconstruction for Fluciclovine (18F) whole body imaging

    Protocol v3.0 dated 5 April 2016 (Appendix B)

    OBJECTIVES
    Primary:
    To evaluate the difference in image quality between BPL and standard PET reconstructions of Fluciclovine (18F) whole body PET images

    Secondary:
    To determine the optimum penalisation factor (β) for Fluciclovine (18F) whole body PET BPL reconstruction.

    To determine the difference in positive detection rates between BPL and OSEM reconstructions.

    Tertiary/Exploratory:
    Future study of other PET reconstruction methods (e.g. new / in development) for Fluciclovine (18F)
    PET imaging
    E.3Principal inclusion criteria
    (1) The subject is a male ≥18 years old.
    (2) 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 BCR on the basis of:
    a. Post RRT / brachytherapy: Increase in PSA level ≥2.0 ng/mL above the nadir level after radiotherapy (RT) or brachytherapy (ASTRO-Phoenix criteria) [53], or
    b. Post 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.
    (3) The subject has not had previous recurrences of PCa, i.e. this is the first diagnosis of BCR.
    (4) The subject is being considered for radical salvage therapy.
    (5) 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.
    (6) The subject’s Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
    (7) The subject should not have received androgen-deprivation therapy within 3 months of screening.
    (8) 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).
    E.4Principal exclusion criteria
    (1) The subject has been previously included in this study.
    (2) 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.
    (3) The subject has known hypersensitivity to fluciclovine (18F) injection or any of its constituents.
    (4) The subject has had a choline PET/CT scan within 3 months of the screening visit.
    (5) The subject has bilateral hip prostheses.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of clinical impact of fluciclovine (18F) in affecting treatment decisions will be assessed by record of the revised treatment plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended treatment plan.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After single dose
    E.5.2Secondary end point(s)
    1. To assess possible improvement in outcome of radical salvage treatment based on fluciclovine (18F) PET/CT being included in the assessment.
    This will be assessed as the proportion of these patients who have a treatment response or treatment failure within the follow-up period, using the following definitions:
    1. Treatment response
    a. ≥50% decline in PSA [5] ±
    b. Radiological response
    2. Treatment failure
    a. Increase or <50% decline in PSA ±
    b. Radiological progression.

    2. To assess the prostate specific antigen (PSA) threshold for positive lesion detection by fluciclovine (18F) PET/CT in biochemical recurrence of prostate cancer (BCR).
    The positive detection rate will be calculated for the overall cohort and across a range of PSA values, to determine the optimum PSA threshold for lesion detection.

    3. To assess the safety of fluciclovine (18F) injection in patients undergoing PET/CT
    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.

    E.5.2.1Timepoint(s) of evaluation of this end point
    1. during the follow-up period.
    2. after single dose
    3. after single dose
    4. end of study
    5. after single dose
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial for an individual patient is defined as 6 months after instigation of their management plan. In the subset of patients who receive salvage therapy, the end of the trial is defined as the date of post-treatment PSA level.

    The end of the study is defined as the date of database lock for data analysis, which is anticipated to occur within 12 weeks after the last patient has completed the 6 months post treatment follow up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Fluciclovine (18F) injection is administered as a single dose for fluciclovine (18F) PET/CT, with no continued provision planned. All participants will receive best standard of care throughout and this will continue without interference following trial completion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-25
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