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    Summary
    EudraCT Number:2019-004685-18
    Sponsor's Protocol Code Number:PSMA-PROSTAPET
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 number2019-004685-18
    A.3Full title of the trial
    Evaluation of diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in primary staging of Intermediate and High Risk Prostatic Cancer in men newly diagnosed
    Valutazione della accuratezza diagnostica della PET/CT con [68Ga]Ga-PSMA-11 nella stadiazione iniziale di uomini con nuova diagnosi di neoplasia prostatica a rischio intermedio o alto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in primary staging of Intermediate and High Risk Prostatic Cancer in men newly diagnosed
    Valutazione della accuratezza diagnostica della PET/CT con [68Ga]Ga-PSMA-11 nella stadiazione iniziale di uomini con nuova diagnosi di neoplasia prostatica a rischio intermedio o alto
    A.3.2Name or abbreviated title of the trial where available
    PSMA-PROSTAPET
    PSMA-PROSTAPET
    A.4.1Sponsor's protocol code numberPSMA-PROSTAPET
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    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 supportRADIUS S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Quality Team
    B.5.2Functional name of contact pointServizio Formazione, Ricerca e Inno
    B.5.3 Address:
    B.5.3.1Street AddressVia del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225868
    B.5.5Fax number0594224369
    B.5.6E-mailricercainnovazione@aou.mo.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 name[68Ga]Ga-PSMA-11
    D.3.2Product code [68GaGa-PSMA-11]
    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.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameComplex of 68-Gallium with (3S,7S)-22-[3-[[[2-[[[5-(2-carboxyethyl)-2-hydroxyphenyl]methyl](carboxymethyl)amino]ethyl](carboxymethyl)amino]methyl]-4-hydroxyphenyl]-5,13,20-trioxo-4,6,12,19-tetraazodocosane-1,3,7-tricarboxylic acid (PSMA-11), supplied as trifluoroacetate salt Synonyms: 68Ga-(2-[3-(1-Carboxy-5-{6-[3-(3-{[(2-{[5-(2-carboxy-ethyl)-2-hydroxy-benzyl]-carboxymethyl-amino}-ethyl)-carboxymethyl-amino]-methyl}-4-hydroxy-phenyl)-propionylamino]-hexanoylamino}); Glu-NH-CO-NH-Lys(Ahx)-[68Ga(
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 60
    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
    Men with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification
    Uomini con conferma istopatologia di tumore prostatico a rischio intermedio o alto, secondo le linee guida PCa EAU del 2019
    E.1.1.1Medical condition in easily understood language
    Men with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification
    Uomini con conferma istopatologia di tumore prostatico a rischio intermedio o alto, secondo le linee guida PCa EAU del 2019
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10036927
    E.1.2Term Prostate neoplasia
    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 diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extra-prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at intermediate or high-risk.
    Valutare l'accuratezza diagnostica della PET/CT con [68Ga]Ga-PSMA-11 nel rilevamento del tumore primario ed extra prostatico (linfonodo, diffusione nei tessuti molli o metastasi ossee) in uomini con nuova diagnosi di neoplasia prostatica a rischio intermedio o alto.
    E.2.2Secondary objectives of the trial
    To compare the diagnostic accuracy of [68 Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or without CT of the lower abdomen and bone scan) in the prostatic bed and extra prostatic disease in men newly diagnosed with prostate cancer at intermediate or high-risk.
    To evaluate correlation between PET PSMA uptake value (SUVmax and SUVmean) and aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).
    Confrontare l'accuratezza diagnostica della PET/CT con [68Ga]Ga-PSMA-11 con l'accuratezza diagnostica delle tecniche di imaging convenzionale mpMRI (con o senza CT del basso addome e scintigrafia ossea) nel rilevamento del tumore primario ed extra prostatico in uomini con nuova diagnosi di neoplasia prostatica a rischio intermedio o alto.
    Valutare la correlazione tra i parametri metabolici della PET/CT (SUV max e SUV mean) e la aggressività del tumore (definita mediante il Gleason Score, i livelli sierici di PSA, il volume del tumore).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    I. Patients with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph)
    II. Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines
    III. Age >18 years/old
    IV. Ability to provide written informed consent
    Per poter partecipare a questo studio, un paziente deve soddisfare tutti i seguenti criteri:
    I. Pazienti con conferma istopatologia di tumore prostatico a rischio intermedio o alto, in accordo alle Linee Guida “Prostate Cancer EAU Guidelines Risk Group Stratification (2019)”
    II. Pazienti sottoposti a Risonanza Magnetica multiparametrica (mpMRI) dell'addome inferiore (accompagnata o no da Tomografia computerizzata a raggi X (TC) e scintigrafia ossea con [99mTc]Tc-HMDP) per la stadiazione iniziale di tumore prostatico, in accordo alle Linee Guida “Prostate Cancer EAU Guidelines Risk Group Stratification (2019)”
    III. Pazienti di età superiore ai 18 anni
    IV. Pazienti in grado di fornire il consenso informato per iscritto
    E.4Principal exclusion criteria
    Patients who meet one of the following criteria:
    I. Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
    II. Impaired renal function
    III. Impaired liver function: AST or ALT > 2.5 x ULN
    IV. Patients unable to understand the purpose of the study
    V. Medical history of allergic reactions or hypersensitivity to [68Ga] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product
    VI. Having partecipated in clinical trial in which the experimental intervention was administered within 30 days (or 5 half-life) from administration the endovenous solution of [68Ga]Ga-PSMA-11
    Pazienti che soddisfano uno dei seguenti criteri:
    I. Controindicazione all’esame PET/TC: pazienti non in grado di eseguire uno studio PET a causa del peso, della claustrofobia o dell'incapacità di rimanere fermi per tutta la durata dell'esame
    II. Pazienti con funzione renale alterata
    III. Pazienti con funzione epatica alterata: AST o ALT > 2.5 x ULN
    IV. Pazienti incapaci di comprendere lo scopo dello studio
    V. Anamnesi di reazioni allergiche o ipersensibilità al principio attivo, a uno qualsiasi degli eccipienti o a uno qualsiasi dei componenti del radiofarmaco marcato
    VI. Partecipazione ad uno studio clinico in cui è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite prima del farmaco in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Diagnostic Accuracy Measures will be estimated as well as their 95% confidence interval.
    For the primary objective, the following index test and reference test will be considered:
    Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment.
    Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months follow-up and up to 24 months after treatment.
    Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via independently.
    PET images will be reviewed for identification of focal [68Ga]Ga-PSMA-11 PET/CT uptake within and outside the prostate.
    A PET positive finding in prostate gland is defined with PSMA equal to or above liver and lower than parotid gland.
    A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes = 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver.
    A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive. [28].
    The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy-proven prostate cancer.
    L'accuratezza diagnostica sarà valutata con un intervallo di confidenza del 95%.
    Per l'obiettivo primario, verranno considerati i seguenti test indice e test di riferimento:
    Test indice: PET/TC con [68Ga] Ga-PSMA-11 PET / CT eseguita prima del trattamento.
    Test di riferimento: valutazione clinica, radiologica e isto-patologica, se disponibile, a 12 mesi di follow-up e fino a 24 mesi dopo il trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 months after treatment
    Fino a 24 mesi dopo il trattamento
    E.5.2Secondary end point(s)
    For the secondary objective, the following index test and reference test will be considered:
    Index test: conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed before treatment
    Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months follow-up and up to 24 months after treatment.
    MRI imaging results will be evaluated by two radiologists specializing in body MRI imaging with the PI-RADS version 2 criteria (21).
    In addition, for the secondary objective, after testing the assumption of normality with the Kolmogorov-Smirnov test, the metabolic PET parameters (SUV max and SUV mean) will be correlated with PSA serum level, by using the Pearson correlation, and with Gleason score and tumor volume, by using the Spearman correlation.
    The SUV of [68Ga]Ga-PSMA-11 will be calculated according to the following formula:
    (measured activity concentration [MBq/mL] * body weight [g]) / injected activity [MBq].
    The SUV max and SUV mean of [68Ga]Ga-PSMA-11 will be evaluated, both for prostate gland suspected lesion and distant suspected localizations.
    Per l'obiettivo secondario, saranno presi in considerazione i seguenti test indice e test di riferimento:
    Test indice: mpMRI (con o senza TC dell'addome inferiore e scansione ossea) eseguita prima del trattamento
    Test di riferimento: valutazione clinica, radiologica e isto-patologica, se disponibile, a 12 mesi di follow-up e fino a 24 mesi dopo il trattamento.

    Inoltre, per l'obiettivo secondario, i parametri metabolici della PET (SUV max e media SUV) saranno correlati con il livello sierico di PSA, usando la correlazione di Pearson, e con il Gleason Score e il volume del tumore, usando la correlazione di Spearman.
    Il SUV del [68Ga] Ga-PSMA-11 sarà calcolato secondo la seguente formula:
    (concentrazione dell'attività misurata [MBq / mL] * peso corporeo [g]) / attività iniettata [MBq].
    Verranno valutati il SUVmedio il SUVmax del [68Ga] Ga-PSMA-11, sia per le sospette lesioni della ghiandola prostatica sia per le sospette localizzazioni extraprostatiche
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 24 months after treatment
    Fino a 24 mesi dopo il trattamento
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    Studio interventistico, monocentrico, in aperto, a singolo braccio, prospettico di accuratezza diagn
    Diagnostic accuracy prospective, single-centre, open-label, single group assignment, interventional
    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 years4
    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 years4
    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.1.1.1In 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    The patients will be treated with best standard of care
    Tutti i pazienti che partecipano allo studio saranno trattati con il miglior standard di cura
    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 Decision2020-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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