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    Summary
    EudraCT Number:2022-003788-13
    Sponsor's Protocol Code Number:1013
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-08-24
    Trial 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 ConcernedFinland - Fimea
    A.2EudraCT number2022-003788-13
    A.3Full title of the trial
    Molecular theranostics for metastatic prostate cancer: PSMA, FAPI, or both?
    Metastaattisen eturauhassyövän teranostiikka: PSMA, FAPI vai molemmat?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Molecular theranostics for metastatic prostate cancer: PSMA, FAPI, or both?
    Levinneen eturauhassyövän teranostiikka: PSMA, FAPI vai molemmat?
    A.3.2Name or abbreviated title of the trial where available
    FAPStera
    A.4.1Sponsor's protocol code number1013
    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 SponsorHeikki Minn
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportValtion hankemääräraha
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportTutkijoiden henkilökohtaiset apurahat
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHeikki Minn
    B.5.2Functional name of contact pointHeikki Minn
    B.5.3 Address:
    B.5.3.1Street AddressTYKS Syöpäklinikka, PL 52
    B.5.3.2Town/ cityTurku
    B.5.3.4CountryFinland
    B.5.6E-mailheikki.minn@utu.fi
    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 name[18F]FAPI-74
    D.3.4Pharmaceutical form 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 No
    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
    Metastatic prostate cancer
    Metastaattinen eturauhassyöpä
    E.1.1.1Medical condition in easily understood language
    Metastatic prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    i) Evaluate the lesion-specific expression of prostate-specific membrane antigen (PSMA) and fibroblast activation-protein (FAP) in metastatic prostate cancer
    E.2.2Secondary objectives of the trial
    ii) Evaluate the potential of fluorine-18 labeled FAP inhibitor (FAPI)-74 positron-emission tomography (PET)/computed tomography (CT) to detect prostate cancer metastases.
    iii) Evaluate the diagnostic accuracy between fluorine-18 labeled DCFPyL PSMA and FAPI-74 using PET/CT imaging
    iv) Evaluate the whole tracer-based metastatic load by calculating DCFPyL PSMA and FAPI-74 activated tumor volumes (TV)
    v) Evaluate the expression of PSMA and FAPI at the tissue level from the original tumor and metastases using immunohistochemistry.
    vi) Evaluate the effect of clinical characteristics (prostate-specific antigen (PSA) doubling time, type of metastases [bone/node/soft tissue], previous therapy) on the uptake of DCFPyL and FAPI-74 to the individual metastases.
    vii) Observe vital signs and adverse events (AE) during imaging
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men with histologically confirmed prostate cancer. Age 50-85 years.
    WHO performance score 0-2.
    At least one distant metastasis detected on CT, MRI, bone scintigraphy (BS) or single-photon emission computed tomography (SPECT) imaging.
    All previous treatment lines are allowed.
    Patient signs informed consent form after receiving written information.
    E.4Principal exclusion criteria
    Patient is not able to understand the purpose of the study.
    Medical conditions prohibiting whole-body PET/CT imaging.
    E.5 End points
    E.5.1Primary end point(s)
    i) The proportion of subject with PSMA- and/or FAPI-positive metastases and number of metastases.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 18F-FAPI-74 PET/CT and 18F- DCFPyL PET/CT imaging.
    E.5.2Secondary end point(s)
    i) The proportion of detected metastasis with 18F-FAPI-74 PET/CT compared to the 18F- DCFPyL PET/CT.
    ii) The sensitivity, specificity, accuracy, and area under the receiver-operating characteristic curve (AUC) values of 18F-DCFPyL PET/CT and 18F-FAPI-74 PET/CT in detecting metastatic subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 18F-FAPI-74 PET/CT and 18F- DCFPyL PET/CT imaging.
    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 No
    E.6.5Efficacy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Standard treatment according to the good clinical care.
    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 Decision2023-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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