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    Summary
    EudraCT Number:2015-003397-33
    Sponsor's Protocol Code Number:IRST185.02
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-003397-33
    A.3Full title of the trial
    68Ga-PSMA HBED-PET/CT in the evaluation of the biochemical relapse in patients with a history of prostate cancer radically treated.
    Utilizzo di 68Ga-PSMA-HBED PET/CT nella valutazione della ripresa biochimica di malattia in pazienti con pregresso carcinoma della prostata trattato radicalmente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    68Ga-PSMA HBED-PET/CT in the evaluation of the biochemical relapse in patients with a history of prostate cancer radically treated.
    Utilizzo di 68Ga-PSMA-HBED PET/CT nella valutazione della ripresa biochimica di malattia in pazienti con pregresso carcinoma della prostata trattato radicalmente.
    A.3.2Name or abbreviated title of the trial where available
    Ga PSMA
    Ga PSMA
    A.4.1Sponsor's protocol code numberIRST185.02
    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 SponsorISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
    B.1.3.4CountryItaly
    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 supportIRST IRCCS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIRST IRCCS
    B.5.2Functional name of contact pointCentro di Coordinamento Studi IRST
    B.5.3 Address:
    B.5.3.1Street AddressDipartimento di Oncologia ed Ematologia, Ospedale Civile S. Maria delle Croci, viale Randi, 5
    B.5.3.2Town/ cityRavenna
    B.5.3.3Post code48121
    B.5.3.4CountryItaly
    B.5.4Telephone number+390544285813
    B.5.5Fax number+390544285330
    B.5.6E-mailcc.ubsc@irst.emr.it
    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-HBED-CC-PSMA_IRSTIRCCS
    D.3.2Product code 68Ga-HBED-CC-PSMA_IRSTIRCCS
    D.3.4Pharmaceutical form Solution for infusion
    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-HBED-CC-PSMA_IRSTIRCCS
    D.3.9.2Current sponsor code68Ga-HBED-CC-PSMA_IRSTIRCCS
    D.3.9.4EV Substance CodeSUB178157
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    carcinoma della prostata
    E.1.1.1Medical condition in easily understood language
    prostate cancer
    carcinoma della prostata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001186
    E.1.2Term Adenocarcinoma of prostate
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the sensitivity of 68Ga-PSMA PET/CT, defined as the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.
    Valutare la sensibilità della PET con Gallio-68 PSMA, definita come il rapporto tra il numero di pazienti positivi alla 68Ga- PSMA PET /CT ed il numero di pazienti con ripresa biochimica e standard imaging negativo.
    E.2.2Secondary objectives of the trial
    - Sensitivity for different PSA values (ranges)
    - Sensitivity for different lesion sites
    - for patients that will start an anticancer treatment: evaluate the predictive role of 68Ga-PSMA PET/CT on early response to therapy (ormonotherapy, abiraterone, enzalutamide) taking PSA decrease as a reference.
    - for patient without any treatment: evaluate the concordance between 68Ga-PSMA PET/CT and other standard methods and eventually optional biopsy
    - Safety
    - sensibilità per diversi ranges di PSA
    - sensibilità per diversi siti di lesioni
    - valutazione della risposta ai trattamenti tramite esecuzione di una seconda PET
    - identificazione di falsi positive durante il FUP (con altri metodi standard o biopsia) nei pazienti che non stano eseguendo nessun trattamento
    - sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have histologically or cytologically confirmed prostate cancer
    2. aged >18 years.
    3. Radical treatment for prostate cancer (radiotherapy or surgery)
    4. 18F-FMC PET/CT negative or doubtful
    5. Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
    1. Pazienti con diagnosi istologica/citologica di tumore della prostata
    2. Età >18 anni
    3. Trattamento radicale con chirurgia o radioterapia del tumore della prostata
    4. PET/TAC con 18F-Colina negativa o dubbia
    5. Pazienti con progressione del PSA definita come PSA ≥ 1,0 ng/mL e/o incremento del PSA definite come 2 aumenti consecutive ad almeno 1 settimana di distanza
    E.4Principal exclusion criteria
    1. No hormonotherapy in the last 6 months
    2. No radiotherapy in the last 6 months.
    3. Patients with PSA < 1.0 ng/ml
    1. Nessuna ormonoterapia negli ultimi 6 mesi
    2. Nessun radioterapia negli ultimi 6 mesi.
    3. Pazienti con PSA <1.0 ng/ml
    E.5 End points
    E.5.1Primary end point(s)
    to evaluate the sensitivity of 68Ga-PSMA PET/CT, defined as the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.
    Valutare la sensibilità della PET con Gallio-68 PSMA, definita come il rapporto tra il numero di pazienti positivi alla 68Ga- PSMA PET /CT ed il numero di pazienti con ripresa biochimica e standard imaging negativo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    1) Sensitivity for different PSA values (ranges)
    2) Sensitivity for different lesion sites
    3) for patients that will start an anticancer treatment: evaluate the predictive role of 68Ga-PSMA PET/CT on early response to therapy (ormonotherapy, abiraterone, enzalutamide) taking PSA decrease as a reference.
    4) for patient without any treatment: evaluate the concordance between 68Ga-PSMA PET/CT and other standard methods and eventually optional biopsy
    5) safety
    1) sensibilità per diversi ranges di PSA
    2) sensibilità per diversi siti di lesioni
    3) Per i pazienti che iniziano una terapia antitumorale: valutazione della risposta ai trattamenti tramite esecuzione di una seconda PET (valutazione del ruolo predittivo della 68Ga-PSMA PET/CT sulla risposta precoce al trattamento (ormonale, abiraterone, enzalutamide) prendendo come riferimento la riduzione del PSA
    4) Per i pazienti che non stano eseguendo nessun trattamento: identificazione di falsi positive durante il FUP (con altri metodi standard o biopsia); valutazione della concordanza tra la 68Ga-PSMA PET/CT e le altre metodiche standard ed eventualmente una biopsia
    5) sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 24 months
    2) 24 months
    3) 24 months
    4) 24 months
    5) 24 months
    1) 24 mesi
    2) 24 mesi
    3) 24 mesi
    4) 24 mesi
    5) 24 mesi
    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 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 No
    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 Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    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.8.2.4Number 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 67
    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)
    It is a diagnostic trial, none defined treatment is provided for subjects at the end of study participation
    La sperimentazione è di tipo diagnostico, non prevede alcun trattamento predefinito dei soggetti al termine della partecipazione allo studio
    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 Decision2015-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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