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    Summary
    EudraCT Number:2020-003183-68
    Sponsor's Protocol Code Number:PSMA-RGS
    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:2021-06-15
    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 number2020-003183-68
    A.3Full title of the trial
    The Role of Imaging Guided Surgery to Improve the Detection of LymphNode metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection
    Il ruolo della chirurgia imaging-guidata nel migliorare l’identificazione di metastasi linfonodali nei pazienti con tumore prostatico trattati con prostatectomia radicale e linfadenectomia pelvica estesa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The implementation of imaging guidance in surgery for patients with prostate cancer who are candidate to undergo robot-assisted prostatectomy and lymph node removal
    Valutazione dell'implementazione della guida tramite immagini intra-operatoria nei pazienti con tumore prostatico candidati a chirurgia radicale.
    A.3.2Name or abbreviated title of the trial where available
    PSMA-RGS
    PSMA-RGS
    A.4.1Sponsor's protocol code numberPSMA-RGS
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportBando della ricerca finalizzata 2018; Giovani Ricercatori (progetto GR2018-12368369)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointUrologia
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226437286
    B.5.5Fax number0226432969
    B.5.6E-mailurologia.sede@hsr.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 name99mTc-PSMA-I&S
    D.3.2Product code [99mTc-PSMA-I&S]
    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 INNPSMA I&S (99mTc-MAS3-y-nal-k(Sub-KuE))
    D.3.9.2Current sponsor code99mTc-PSMA I&S
    D.3.9.3Other descriptive namePSMA I&S (99mTc-MAS3-y-nal-k(Sub-KuE))
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 360
    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.IMP: 2
    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-HBED-CC]
    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 INNPSMA-HBED-CC (PSMA-11)
    D.3.9.2Current sponsor code68Ga-PSMA
    D.3.9.3Other descriptive name68Ga-PSMA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number110 to 210
    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
    Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data
    Pazienti affetti da tumore della prostata candidati a intervento chirurgico di prostatectomia radicale robot-assistita con un rischio di invasione linfonodale >5% secondo i dati preoperatori
    E.1.1.1Medical condition in easily understood language
    Prostate cancer with intermediate/high preoperative risk of lymph nodal metastases
    Tumore della prostata a rischio di metastasi linfonodali
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10026389
    E.1.2Term Malignant neoplasm 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
    The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in this setting.
    L'obiettivo principale dello studio è quello di migliorare l'abilità da parte dei chirurghi di identificare l'invasione linfonodale da parte del tumore della prostata nei pazienti sottoposti a prostatectomia radicale robot-assistita con linfadenectomia pelvica estesa e di valutare il ruolo del 99mTc-PSMA-I&S in questo setting.
    E.2.2Secondary objectives of the trial
    1. To optimize the synthesis of 99mTc-PSMA-I&S
    2. To assess the safety and tolerability of the administration of 99mTc-PSMA-I&S
    3. To assess the diagnostic accuracy of 99mTc-PSMA-RGS in the identification of LNI in men at higher risk for LNI and to compare its predictive accuracy to preoperative 68Ga-PSMA PET/MRI and to available predictive tools such as the Briganti nomogram.
    4. To assess whether 99mTc-PSMA-RGS would allow for the identification of positive nodes outside the anatomically defined ePLND template, which includes the internal and external iliac as well as the obturator lymphatic landing sites.
    1. Ottimizzare la sintesi del 99mTc-PSMA-I&S
    2. Determinare la sicurezza e tollerabilità della somministrazione di 99mTc-PSMA-I&S
    3. Determinare l'accuratezza diagnostica del 99mTc-PSMA-I&S nell'identificazione dell'invasione linfonodale nei pazienti ad alto rischio di metastasi linfonodali e comparare l'accuratezza predittiva del 68Ga-PSMA PET/MRI e degli strumenti attualmente disponibili quali il Briganti nomogram
    4. Determinare se l'utilizzo della chirurgia radio-guidata previa somministrazione di 99mTc-PSMA-I&S possa portare all'identificazione di linfonodi positivi al di fuori del template della linfadenectomia pelvica estesa bilaterale (iliaci interni, esterni e otturatori)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male patients
    - Age between 18 and 80 years
    - Biopsy proven PCa with a LNI risk >5% according to the Briganti nomogram
    - Planned to receive a RARP with an ePLND
    - Able to understand and willing to sign a written informed consent document
    - Maschi
    - Età tra 18 e 80 anni
    - Tumore della prostata alla biopsia con un rischio di invasione linfonodale >5% secondo il nomogramma di Briganti
    - Pazienti candidati a ricevere una prostatectomia radicale robot-assistita con linfadenectomia pelvica estesa bilaterale
    - Pazienti in grado di comprendere e firmare il consenso informato
    E.4Principal exclusion criteria
    - Receipt of neoadjuvant therapies
    - Inability to complete the imaging examinations according to the prospective protocol
    - Evidence of metastatic disease at conventional imaging before surgery
    - Evidence of clinical lymphadenopathies at conventional imaging before surgery
    - Life expectancy of less than 12 months
    - Previous chemotherapy
    - Previous brachytherapy or external beam radiotherapy
    - Unstable cardiovascular disease
    - Congestive Heart Failure (CHF)
    - Clinically significant hepatobiliary or renal disease
    - History of significant CNS injuries within 6 months
    - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
    - Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA)
    - Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself
    - Assunzione di terapie neoadiuvanti
    - Impossibilità a completare gli esami richiesti durante lo studio
    - Evidenza di malattia in stadio metastatico (M+) all’imaging convenzionale
    - Evidenza di linfoadenopatie (cN+) all’imaging convenzionale
    - Aspettativa di vita inferiore a 12 mesi
    - Storia di tumori trattati con chemioterapia
    - Precedente brachiterapia o radioterapia per tumore della prostata
    - Malattia cardiovascolare instabile
    - Scompenso cardiaco, IRC, disturbi del sistema nervoso centrale o altre malattie croniche invalidanti
    - Malattie epatobiliari o renali significative
    - Storia di danni al sistema nervoso centrale negli ultimi 6 mesi
    - Qualsiasi altra malattia significativa che possa porre il partecipante a rischio o influenzare i risultati dello studio
    - Storia di allergie o reazioni che possono essere esacerbate dagli IMP utilizzati nello studio (99mTc-PSMA-I&S and 68Ga-PSMA)
    - Pazienti che hanno ricevuto trattamenti sperimentali in trial clinici entro 30 giorni dalla somministrazione del radiotracciante in questo studio o entro 5 emivite del farmaco sperimentale
    E.5 End points
    E.5.1Primary end point(s)
    Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (namely, histopathological evaluation of the lymph nodes done by a dedicated high-volume uro-pathologists, the results are typically available 10 days after surgery).
    Rate di invasione linfonodale all'esame istologico finale dopo chirurgia radioguidata previa somministrazione di 99mTc-PSMA-I&S
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 days
    10 giorni
    E.5.2Secondary end point(s)
    Side effects associated with the administration of 99mTC-PSMA-I&S; Rate of intraoperative complications associated with 99mTc-PSMA-RGS assessed at visit 2; Rate of postoperative complications associated with 99mTc-PSMA-RGS assessed; Rate of LNI observed at final pathology in nodes outside the extended nodal dissection template detected only by 99mTc-PSMA-RGS
    Effetti collaterali associati alla somministrazione di 99mTC-PSMA-I&S; Frequenza di complicanze intraoperatorie associate alla chirurgia radio-guidata; Frequenza di complicanze postoperatorie associate alla chirurgia radio-guidata; Invasione linfonodale osservata all'esame istologico definitivo nei linfonodi al di fuori del template della linfadenectomia pelvica estesa identificati tramite 99mTc-PSMA-RGS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 84 days; Day 28; Day 84; Day 10
    Entro 84 giorni; Giorno 28; Giorno 84; Giorno 10
    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 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 years3
    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 years3
    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)
    Prosecution of postoperative follow-up for prostate cancer in accordance with international guidelines (EA)U guidelines on Prostate Cancer – 2019)
    Prosecuzione del follow-up del tumore della prostata come da linee guida internazionali (EAU guidelines on Prostate Cancer – 2019).
    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 Decision2020-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-16
    P. End of Trial
    P.End of Trial StatusOngoing
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