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    Summary
    EudraCT Number:2019-002000-41
    Sponsor's Protocol Code Number:IRST185.07
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-05
    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 number2019-002000-41
    A.3Full title of the trial
    Experimental study to evaluate the impact of 18F-PSMA PET / CT in the management of patients with prostate cancer.
    Studio sperimentale per valutare l'impatto della PET / TC 18F-PSMA nella gestione dei pazienti con carcinoma della prostata.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Experimental study to evaluate the effect of PET/TC using 18F-PSMA label in the management of patients with prostate cancer.
    Studio sperimentale per valutare l'effetto dell'utilizzo della molecola tracciante 18F-PSMA nella PET/TC nella gestione dei pazienti con carcinoma alla prostata.
    A.3.2Name or abbreviated title of the trial where available
    F-PSMA
    F-PSMA
    A.4.1Sponsor's protocol code numberIRST185.07
    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 "S.Maria delle Croci" - Viale Randi, 5
    B.5.3.2Town/ cityRavenna
    B.5.3.3Post code48121
    B.5.3.4CountryItaly
    B.5.4Telephone number0544285813
    B.5.5Fax number0544285330
    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 name18F-PSMA-1007_IRSTIRCCS
    D.3.2Product code [18F-PSMA-1007_IRSTIRCCS]
    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-PSMA-1007_IRSTIRCCS
    D.3.9.2Current sponsor code18F-PSMA-1007_IRSTIRCCS
    D.3.9.4EV Substance CodeSUB198132
    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
    Tumore alla 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 10029002
    E.1.2Term Neoplasm of the 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
    The primary objective of this phase II study is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.
    L'obiettivo principale di questo studio di fase II è valutare la sensibilità della PET / CT con 18F-PSMA, definito come il rapporto tra il numero di pazienti positivi alla PET / TC con 18F-PSMA e il numero di pazienti affetti da pregresso carcinoma della prostata, con sospetta recidiva biochimica e imaging standard negativo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - Sensitivity for different PSA values (ranges)
    - Sensitivity for different lesion sites
    - For patients that will start an anticancer treatment: evaluate the predictive role of 18F-PSMA PET/CT on disease status up to 6 months follow up performed according to standard imaging and PSA evaluation
    - For patients without any treatment: evaluate the concordance between 18F-PSMA PET/CT and other methods such as D-WB-MRI and possibily biopsy up to 6 months of follow up
    - Safety
    Gli obiettivi secondari sono:
    - Sensibilità per diversi valori di PSA (ranges)
    - Sensibilità per le diverse lesioni
    - Per i pazienti che inizieranno un trattamento antitumorale: valutare il ruolo predittivo di PET/CT 18F-PSMA sullo stato di malattia fino a 6 mesi di follow up, attraverso l'imaging standard e la valutazione del PSA
    - Per i pazienti non in trattamento: valutazione della concordanza tra 18FPSMA PET / CT e altri metodi come la D-WB-MRI ed eventualmente la biopsia fino a 6 mesi di follow up
    - Sicurezza
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have histologically or cytologically confirmed prostate cancer
    2. Male, aged >18 years on the day of signing and dating the informed consent form.
    3. Previous radical treatment for prostate cancer (radiotherapy or surgery)
    4. Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
    5. Patients with PSA progression defined as PSA = 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
    6. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
    7. Participant is willing and able to give informed consent for participation in the study.
    1. I pazienti devono avere carcinoma prostatico confermato da diagnosi istologica o citologica.
    2. Maschio, di età> 18 anni, il giorno della firma del modulo di consenso informato.
    3. Pazienti sottoposti a trattamento radicale del cancro alla prostata (radioterapia o chirurgia) per un tumore prostatico
    4. Negativi ad altri metodi di imaging tradizionali morfologici e funzionali o dubbio per l'imaging con 18F-FMC PET/CT
    5. Pazienti in progressione con PSA definita come PSA = 0,2 ng/mL e aumento di PSA definito da 2 valori successivi a distanza di almeno 1 settimana
    6. Maschi con partner in età fertile devono acconsentire ad utilizzare o fare utilizzare alla partner metodi contraccettivi efficaci per tutta la durata dello studio e per i 3 mesi successivi al termine dello stesso
    7. I partecipanti devono acconsentire a ed essere in grado di dare consenso informato per la partecipazione allo studio.
    E.4Principal exclusion criteria
    1. Hormonotherapy in the last 6 months
    2. No radiotherapy in the last 6 months.
    3. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
    4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
    5. Medical or psychological conditions that would not permit the subject to sign the informed consent.
    1. Ormonoterapia negli ultimi 6 mesi
    2. Radioterapia negli ultimi 6 mesi
    3. Partecipazione ad altri studi clinici con altri farmaci sperimentali negli ultimi 30 giorni
    4. Storia clinica di reazioni allergiche attribuite a composti di composizione chimica o biologica simile al composto studiato
    5. Condizione medica o psicologica che non consentirebbe al soggetto di firmare il consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the sensitivity of the 18F-PSMA PET/CT in prostate cancer patients.
    Sensitivity is defined as the ratio between the number of 18F-PSMA PET / CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.
    Valutazione della sensibilità della PET / TC con 18F-PSMA nei pazienti con carcinoma prostatico.
    La sensibilità è definita come il rapporto tra il numero di pazienti positivi alla 18F-PSMA PET / CT e il numero dei pazienti con recidiva biochimica e imaging standard negativo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Just after 18F-PSMA PET/CT
    L’endpoint primario ed alcuni secondari verranno rilevati contestualmente all’esecuzione della 18F-PSMA PET/CT, poiché si tratta di confrontare l’esito di questa PET con l’imaging da pratica clinica già eseguito in accordo alle linee guida che, secondo quanto definito nei criteri di inclusione, è risultato negativo o dubbio.
    E.5.2Secondary end point(s)
    Sensitivity for different PSA values (ranges); Sensitivity for different lesion sites; For patients that will start an anticancer treatment: evaluate the predictive role of 18FPSMA PET/CT on disease status up to 6 months of follow up performed according to standard imaging and PSA evaluation.; For patient without any treatment: evaluate the concordance between 18F-PSMA PET/CT and other methods such as D-WB-MRI and possibly optional biopsy; Safety
    Sensibilità a diversi valori di PSA (range); Sensibilità per diversi siti di lesione; Per i pazienti che inizieranno un trattamento antitumorale: valutare il ruolo predittivo di PET/CT 18F-PSMA sullo stato di malattia fino a 6 mesi di follow up, attraverso imaging standard e valutazione del PSA.; Per i pazienti che non sono sottoposti a trattamento: valutazione della concordanza tra 18F-PSMA PET / CT e altri metodi standard ed eventualmente biopsia opzionale; Sicurezza
    E.5.2.1Timepoint(s) of evaluation of this end point
    Just after 18F-PSMA PET/CT; Just after 18F-PSMA PET/CT; Up to 6 months of follow up.; Up to 6 months of follow up.; Up to 30 days after 18F-PSMA PET/CT.
    Contestualmente all’esecuzione della 18F-PSMA PET/CT; Contestualmente all’esecuzione della 18F-PSMA PET/CT; La rilevazione verrà fatta fino a 6 mesi dalla fine del trattamento, in coincidenza con le successive rivalutazione standard del paziente.; La rilevazione verrà fatta fino a 6 mesi dalla fine del trattamento, in coincidenza con le successive rivalutazione standard del paziente.; Fino a 30 giorni successivamente alla 18F-PSMA PET/CT.
    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 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.8.2.4Number 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.8.6 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 months6
    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 months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    Since it is a diagnostic trial, there is not a defined treatment for the subjects at the end of the study
    La sperimentazione è di tipo diagnostico e 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 Decision2019-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-17
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