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    Summary
    EudraCT Number:2014-005073-37
    Sponsor's Protocol Code Number:I-1409
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-005073-37
    A.3Full title of the trial
    68Ga-PSMA PET/CT for detection of recurrent prostate cancer: Comparison with 18F-fluoride PET/CT, MRI and DW-MRI
    68Ga-PSMA PET/CT til at identificere prostatacancer recidiv: sammenligning med 18F-fluorid PET/CT, MRI and DW-MRI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of three methosd to identify prostate cancer relapse in patient who precviously have been through curative intended threapy
    Sammenligning af tre metoder til påvisning af tilbagefald hos patienter, der tidligere har modtaget helbredende behandling for prostatakræft
    A.4.1Sponsor's protocol code numberI-1409
    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 SponsorDepartment of Nuclear Medicine, Aalborg University Hospital
    B.1.3.4CountryDenmark
    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 supportThe Obel Family Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Nuclear Medicine, Aalborg University Hospital
    B.5.2Functional name of contact pointLars Jelstrup Petersen
    B.5.3 Address:
    B.5.3.1Street AddressHobrovej 18-22
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4597665484
    B.5.6E-maillajp@rn.dk
    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 name68Ga-PSMA-HBED-CC
    D.3.2Product code 68Ga-PSMA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN68Ga-PSMA-HBED-CC
    D.3.9.3Other descriptive name68Ga-‘2-[3-(1-Carboxy-5-{6-[3-(3-{[(2-{[4-(2-carboxy-ethyl)-2-hydroxy-benzyl]-carboxymethyl-amino}-ethyl)-carboxymethyl-amino]-methyl}-4-hydroxy-phenyl)-propionylamino]-hexanoylamino}-pentyl)-ureido]-pentanedioic acid
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 name18F-Fluoride
    D.3.2Product code NaF-18
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN18F-Fluoride
    D.3.9.3Other descriptive nameFLUORIDE
    D.3.9.4EV Substance CodeSUB21927
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number180 to 220
    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
    Patients diagnosed with biochemical (PSA) relapse following curative intended treatment (defined as radical prostatectomy or radiotherapy, either by external beam radiotherapy or low- or high-dose brachytherapy, or any combination of these) will be included in this study.
    Patienter diagnosticeret med biokemisk recidiv efter kurativ intenderet behandling (defineret som radikal prostatektomi eller stråleterapi, enten ved ekstern stråleterapi eller ved lav- eller højdosis brachyterapi, eller en kombination af disse) vil blive inkluderet i dette forsøg.
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with prostate cancer relapse following previously treatment.
    Patienter med tilbagevendende prostatakræft efter helbredende behandling vil deltage i forsøget.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10036223
    E.1.2Term Positron emission tomography
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate if 68Ga-PSMA PET/CT can detect prostate cancer recurrence, particularly at low PSA levels, and to identify if recurrence is confined to the prostatic bed, lymph nodes and/or bones.
    At undersøge om 68Ga-PSMA PET/CT kan detektere prostatacancer recidiv, specielt ved lave PSA værdier, og identificere om recidivet begrænset til prostatalejet, lymfeknuder og/eller knogler.
    E.2.2Secondary objectives of the trial
    To investigate if 68Ga-PSMA PET/CT is superior to anatomical MRI as well as diffusion-weighted (DW-) MRI in the detection of local recurrence, lymph node metastases and bone metastases in the axial skeleton in prostate cancer recurrence.
    To assess if 68Ga-PSMA PET/CT is superior to 18F-fluoride PET/CT in the detection of bone metastases in patients with prostate cancer recurrence at whole body level.
    To evaluate the added clinical value of 68Ga-PSMA PET/CT in terms of change of management by access to the results of 68Ga-PSMA PET/CT and anatomical MRI. A post-hoc analysis will be made with DW-MRI (which is read after the end of the study).
    At undersøge om 68Ga-PSMA PET/CT er bedre end anatomisk MR og diffusionsvægtet-MR til at detektere lokal recidiv, lymfeknude- og knoglemetastaser i det aksiale skelet ved prostatacancer recidiv.
    At vurdere om 68Ga-PSMA PET/CT er bedre end 18F-fluorid PET/CT til at detektere knoglemetastaser i patienter med prostatacancer recidiv i en helkropsskanning.
    At evaluere om 68Ga-PSMA PET/CT har en øget klinisk værdi i form af en ændret behandlingsstrategi ud fra resultaterne af 68Ga-PSMA PET/CT og anatomisk MR. En post hoc-analyse vil blive lavet med diffusionsvægtet MR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject is eligible for the study if all of the following apply:
    Oral and written informed consent.
    18 years and older.
    The patient has undergone a curatively intended treatment for prostate cancer, which is considered to be radical at the end of the intervention/procedure.
    Confirmed PCa recurrence (defined as PSA ≥ 0.2 ng/ml or more after radical prostatectomy or a rise of 2.0 ng/ml above the post-treatment PSA-nadir following radiation therapy).
    Subject is able to lie still for the duration of the imaging procedure.
    Mundtlig og skriftlig informeret samtykke.
    18 år og ældre.
    Patienten har været igennem et forløb med kurativ intenderet behandling for prostatacancer, hvilket ansås som radikal efter interventionen/proceduren.
    Bekræftet prostatacancer recidiv (defineret som PSA ≥ 0.2 ng/ml eller mere efter radikal prostatektomi eller stigning på 2.0 ng/ml over PSA-nadir efter stråleterapi).
    Patienten skal kunne ligge stille under billeddannelsesproceduren.
    E.4Principal exclusion criteria
    History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer and prostate cancer.
    History of allergic reactions attributed to compounds of 68Ga-PSMA radiotracer.
    Subjects unable to undergo the PET/CT imaging procedure due to claustrophobia despite oral anxiolytics (institutional procedure).
    Subjects weighing greater than 180 kilograms (weight limit for scanner table), or unable to fit within the imaging gantry.
    Subjects with any medical condition or other circumstances (e.g. claustrophobia, unable to lie still, unable to comply with study procedures etc.) that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.
    If the patient refuses MRI or is not eligible (e.g. claustrophobia or other reasons as outlined in the ESUR guideline for MRI), the patient will be offered a diagnostic CT in combination with 68Ga-PSMA PET. If the patient refuses a diagnostic CT scan or allergic or ineligible for such procedure only a 68Ga-PSMA PET/low dose CT will be performed. Such patients will be assessed for secondary endpoints only.
    Anden cancersygdom inden for de seneste fem år bortset fra kurativ behandlet non-melanom hudcancer og prostatacancer.
    Allergisk reaktion mod indholdsstoffer i 68Ga-PSMA sporstoffet.
    Patienter ude at stand til at gennemføre 68Ga-PSMA PET/CT skanningen (fx pga. klaustrofobi til trods for behandling med oral anxiolytikum).
    Patienter med kropsvægt over 180 kr (vægtbegrænsning for skanner) eller med andre begrænsninger i forhold til skannerens størrelse.
    Patienter med en sygdomstilstand eller andre omstændigheder (fx klaustrofobi, manglende evne til at ligge stille eller lignende), der efter investigators opfattelse vil nedsætte datapålidelighed samt muligheden for at gennemføre studiet.
    Hvis patienten nægter eller af andre årsager ikke er i stand til at gennemføre MR-skanningen, vil aptienten tilbydes en diagnostisk CT-skanning i kombination med 68Ga-PSMA PET-skanningen. Patienter, der nægter, er allergiske eller på anden måde uegnet til diagnostisk CT, vil få udført en 68Ga-PSMA PET i kombination med en lavdosis CT-skanning. Disse patienter vil kun blive evalueret i forhold til de sekundære endepunkter.
    E.5 End points
    E.5.1Primary end point(s)
    Detection rate of prostate cancer recurrence at low PSA levels for 68Ga-PSMA PET/CT.
    Detektionsraten for 68Ga-PSMA PET/CT til at detektere prostatacancer recidiv ved lave PSA værdier.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will happen continually as a patient completes the study specific imaging modalities.
    Evaluering vil ske løbende i forbindelse med, at patienterne gennemføre de studie-specifikke skanninger.
    E.5.2Secondary end point(s)
    Comparison of 68Ga-PSMA PET/CT with anatomical and DW-MRI of lesion-based detection rate of prostate cancer recurrence.
    Comparison of 68Ga-PSMA PET/CT and 18F-Fluoride PET/CT in detection of bone metastases.
    The impact of 68Ga-PSMA PET/CT if patient management
    Sammenligning af detektionsrate mellem 68Ga-PSMA PET/CT og anatomisk og DW-MRI på læsions-basis hos patienter med prostatacancer recidiv.
    Sammenligning af 68Ga-PSMA PET/CT og 18F-Fluorid PET/CT ved detektion af knoglemetastaser.
    Evaluering af den kliniske værdi af 68Ga-PSMA PET/CT i forbindelse med behandlingsstrategi.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will happen continually as a patient completes the study specific imaging modalities.
    Evaluering vil ske løbende i forbindelse med, at patienterne gennemføre de studie-specifikke skanninger.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    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 Investigator can exclude the patient from the study due to serious adverse event (SAE), serious adverse reaction (SAR), suspected unexpected serious adverse reaction (SUSAR) or severe non-compliance with study procedures.
    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: 60
    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 state70
    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)
    None.
    Ingen.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Department of Urology, Aalborg University Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Department of Urology, Viborg Regionale Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Department of Radiology, Aalborg University Hospital
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Department of Diagnostic Radiology, The Institut of Cancer Research
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Department of Urology, Holstebro Regional Hospital
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-09
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