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    Summary
    EudraCT Number:2016-004371-51
    Sponsor's Protocol Code Number:PSMA-study
    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:2021-06-08
    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 number2016-004371-51
    A.3Full title of the trial
    68Ga-PSMA-PET/CT for detection of recurrent prostate cancer
    Utilizzo della PET/TC con 68Ga-PSMA nella rilevazione di recidiva in pazienti con neoplasia prostatica in progressione biochimica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    68Ga-PSMA-PET/CT
    Utilizzo della PET/TC con 68Ga-PSMA nella rilevazione di recidiva in pazienti con neoplasia prostatica in progressione biochimica
    A.3.2Name or abbreviated title of the trial where available
    68Ga-PSMA-PET/CT
    68Ga-PSMA-PET/CT
    A.4.1Sponsor's protocol code numberPSMA-study
    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 USL DELLA VALLE D'AOSTA
    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 supportAzienda Ospedaliera della Valle d'Aosta
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera della Valle d'Aosta
    B.5.2Functional name of contact pointS.C. Medicina Nucleare
    B.5.3 Address:
    B.5.3.1Street AddressViale Ginevra 3
    B.5.3.2Town/ cityAosta
    B.5.3.3Post code11100
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 0165543311
    B.5.5Fax number0039 0165543655
    B.5.6E-mailcpoti@ausl.vda.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
    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.3.11 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
    Biochemical recurrence in patients with prostate cancer after radical prostatectomy and/or radiotherapy, no CRPC status
    Pazienti con neoplasia prostatica in progressione biochimica dopo prostatectomia radicale o radioterapia, non CRPC
    E.1.1.1Medical condition in easily understood language
    Biochemical recurrence in patients with prostate cancer after radical prostatectomy and/or radiotherapy, no castration resistant status
    Pazienti con neoplasia prostatica in progressione biochimica dopo prostatectomia radicale o radioterapia, non castrazione resistenti
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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 20.0
    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 21.1
    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 20.1
    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
    Sensitivity of 68Ga-PSMA PET/CT imaging in detection of recurrent prostate cancer in patient with low PSA level (<4 ng/ml)
    Stima della sensibilit¿ della metodica PET/TC con 68Ga-PSMA nella rilevazione di recidiva di malattia in pazienti con bassi livelli di PSA (<4 ng/ml)
    E.2.2Secondary objectives of the trial
    Correlation of detection rate with PSA value, primary Gleason Score and antiandrogen therapy

    Clinical management changes based on PET imaging findings
    Correlazione della percentuale di rilevazione della recidiva con il valore di PSA, lo score di Gleason e la terapia antiandrogenica in corso


    Percentuale di pazienti in cui il riscontro PET ha comportato una modificazione di strategia terapeutica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age>45

    2.Ability to provide informed written consent. All subjects must sign an informed consent form indicating their understanding investigationale nature of study

    3.ECOG 0-1

    4.Hystologically confirmed prostate cancer

    5.Previous prostatectomy and/or radiotherapy

    6.Biochemical recurrence confirmed by elevated PSA value following initial therapy (recent blood test results up to 4 weeks):
    - For patients status post prostatectomy, a PSA >/= 0.2 ng/ml and < 4 ng/ml
    - For patient status post radiation therapy for prostate cancer, any PSA increase from radiation therapy nadir but < 4 ng/ml

    7.Recent blood test results (up to 4 weeks) as follows: WBC=3000/mm3 , Absolute neutrophil count ANC=1500/mm3, PLT=100000/mm3 , Hb=10 g/dl, Total bilirubin = 2.0 mg/dL, ALT and AST = 2.5 x the upper limit of normal, Serum creatinine <1.5 x ULN
    1.Età>45

    2.Sottoscrizione del consenso informato

    3.ECOG 0-1

    4.Tumore della prostata confermato istologicamente

    5.Pregressa prostatectomia e/o radioterapia

    6.Recidiva biochimica confermata da rialzo del PSA (esami ematici entro le 4 settimane):
    - per pazienti post prostatectomia PSA >/= 0.2 ng/ml and < 4 ng/ml
    - per pazienti radiotrattati, qualsiasi rialzo rispetto al nadir ma < 4 ng/ml

    7.Recenti esami ematochimici (entro le 4 settimane): WBC=3000/mm3 , ANC=1500/mm3, PLT=100000/mm3 , Hb=10 g/dl, Bilirubina Totale = 2.0 mg/dL, ALT and AST = 2.5 volte il limite superiore di norma, Creatinina sierica <1.5 volte il limite superiore di norma
    E.4Principal exclusion criteria
    1.Inability to stay lay for the entire imaging time (e.g. cough, severe arthritis, etc)

    2.Inability to complete the needed investigational due to others reasons (severe claustrophobia unresponsive to oral anxiolytics, radiation phobia, etc)

    3.Patients with known CRPC status, as defined by EAU Guidelines and urologists or medical oncologists evaluation

    4.Prior or concomitant chemotherapy

    5.Partecipation in another clinical trial with any investigational agents within 4 weeks prior to study screening or within five half-lives of the drug

    6.Patients exceeding the weight limitations of the scanner ore are not able to enter the bore of the PET scanner due to BMI

    7.Other concomitant or previous malignancies, with the exception of basal cell skin tumors/superficial bladder cancer and any cancer that has been in complete remission for > 5 years.

    8.Recovery from major trauma including surgery within 4 weeks prior to PET imaging

    9.Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
    1.Impossibilità a mantenere la posizione ottimale per tutta la durata dell'indagine (p.e. tosse, severa artrite...)

    2.Claustrofobia

    3.Pazienti castrazione resistenti (CRPC status) come definito dalle linee guida EAU e da valutazione urologica/oncologica

    4.Precedente o concomitante chemioterapia

    5.Partecipazione ad altro trial clinico con farmaci sperimentali nelle 4 settimane precedenti lo screening o entro 5 emivite del farmaco

    6.Peso superiore al limite del tomografo

    7.Altre neoplasie concomitanti o pregresse non in remissione da più di 5 anni, ad eccezione dei basaliomi, neoplasie vescicali in situ

    8.Recenti traumi o interventi chirurgici nelle 4 settimane precedenti all'imaging

    9.Patologie infettive in atto o condizioni patologiche severe che possano interferire con l'esame e sottoporre il paziente a rischio indebito
    E.5 End points
    E.5.1Primary end point(s)
    Ability of 68Ga-PSMA PET/CT to identify prostate cancer recurrence in patient with low PSA level (<4 ng/ml)
    Capacità di rilevare sedi di recidiva con la metodica PET/TC con 68Ga-PSMA nei pazienti con bassi livelli di PSA (<4 ng/ml)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Correlation of detection rate with PSA value, primary Gleason Score and antiandrogen therapy
    Correlazione della percentuale di rilevazione della recidiva con il valore di PSA, lo score di Gleason e la terapia antiandrogenica in corso
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 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 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 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) 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.8.4.1Number 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 years1
    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 years1
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    Follow-up visits are performed every 12 weeks after 68Ga-PSMA imaging (for a maximum of 6 months for the last patient observed)
    Follow-up clinico ogni 12 settimane per massimo sei mesi dall'esecuzione dell'esame PET
    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 Decision2017-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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