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    Summary
    EudraCT Number:2019-003346-32
    Sponsor's Protocol Code Number:ET-19-194
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-20
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-003346-32
    A.3Full title of the trial
    PREFAcE : Interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment
    PREFAcE : Intérêt de l’imagerie par TEP-PSMA potentialisée par un blocage androgénique chez les patients en rechute biologique ou en maladie biologique persistante d’un adénocarcinome prostatique localisé après traitement initial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Interest of PET-PSMA Imaging potentialised by androgen blockade in localized prostatic adenocarcinoma in relapse or reccurent disease
    Interet de la TEP-PSMA potentialisé par un blocage androgénique chez les patients en rechute biologique ou en maladie biologique persistante d’un adénocarcinome prostatique localisé après traitement initial
    A.3.2Name or abbreviated title of the trial where available
    PREFAcE
    PREFAcE
    A.4.1Sponsor's protocol code numberET-19-194
    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 SponsorCentre Léon Bérard
    B.1.3.4CountryFrance
    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 supportMédecine nucléaire / Centre Léon Bérard
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Léon Bérard
    B.5.2Functional name of contact pointMédecine nucléaire
    B.5.3 Address:
    B.5.3.1Street Address28 rue Laennec
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69373 Cedex 08
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)478 78 26 82
    B.5.5Fax number+33(0)478 78 29 06
    B.5.6E-mailseverine.metzger@lyon.unicancer.fr
    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 Yes
    D.2.1.1.1Trade name Firmagon
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    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
    Patient with Prostate Adenocarcinoma in biological relapse or in biological recurrent disease
    Patients en rechute biologique ou en maladie biologique persistante d’un adénocarcinome prostatique localisé après traitement initial
    E.1.1.1Medical condition in easily understood language
    Prostate Adenocarcinoma in biological relapse or in biological recurrent disease
    Adénocarcinome prostatique en rechute ou maladie persistente
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 potentiating effect of androgen blockade on PET-PSMA uptake of prostate adenocarcinoma lesions
    Évaluer l’effet potentialisateur du blocage androgénique sur la révélation des lésions d’adénocarcinome prostatique par une TEP-PSMA
    E.2.2Secondary objectives of the trial
    • To study the reproducibility of the interpretation of initial PET-PSMA and H-PSMA PET.
    • To evaluate the impact of androgen blockade on foci revealed by H-PSMA-PET compared to initial PET-PSMA-PET;
    •To evaluate the impact of initial PET-PSMA and PET-PSMA-H on changes in therapeutic management modalities;
    •To evaluate the value of late pelvic acquisition;
    •To study the correlation between the results of each PET-PSMA scan with clinical, histological data of the primary tumour and biological data of recurrence (PSA kinetics and velocity evaluated from the data available at the time of screening);
    • To study the correlation between changes in PSA and testosterone levels (between D0 and D14) and the results of the PET-PSMA scans;
    •To evaluate the tolerance profile.

    • Étudier la reproductibilité de l’interprétation de la TEP-PSMA initiale et de la TEP-PSMA-H.
    • Évaluer l’impact du blocage androgénique sur les foyers révélés par la TEP-PSMA-H en comparaison avec la TEP-PSMA initiale ;
    • Évaluer l’impact de la TEP-PSMA initiale et de la TEP-PSMA-H sur les modifications de modalités de prise en charge thérapeutique ;
    • Évaluer l’intérêt de l’acquisition tardive pelvienne ;
    • Étudier la corrélation des résultats de chaque TEP-PSMA aux données cliniques, histologiques de la tumeur primitive et biologiques de la récidive (cinétique et vélocité du PSA évaluées à partir des données disponibles au moment du screening) ;
    • Étudier la corrélation entre les variations des taux de PSA et de testostéronémie (entre J0 et J14) et les résultats des TEP-PSMA ;
    • Evaluer le profil de tolérance.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    In case of envisaged irradiation, impact on the changes in irradiation volumes between PET-PSMA and PET-PSMA-H
    • En cas d’irradiation envisagée, impact sur les modifications de volumes d’irradiation entre la TEP-PSMA et la TEP-PSMA-H : étude ancillaire
    E.3Principal inclusion criteria
    I1. Age ≥ 18 years old;
    I2. Hormone-naive patients, initially treated curatively by prostatectomy for prostate adenocarcinoma and having a first or new biological recurrence (PSA greater than 0.2 ng/ml; confirmed on two samples one week apart) OR Hormone-naive patients, initially treated curatively by external radiotherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed in two samples one week apart) OR hormone-naive patients treated by surgery or external radiotherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy);
    I3. Diagnostic recurrence assessment by pelvic MRI revealing no lesion, or having revealed local recurrence or ganglion lesions which may be due to external irradiation
    I4. Signed informed consent.

    I1. Age ≥ 18 ans ;
    I2. Patients naïfs d’hormonothérapie, traités initialement de façon curative par prostatectomie pour un adénocarcinome de prostate et présentant une première ou une nouvelle récidive biologique (PSA supérieur à 0,2 ng/ml; confirmé sur deux prélèvements espacés d’une semaine) OU Patients naïfs d’hormonothérapie, traités initialement de façon curative par radiothérapie externe pour un adénocarcinome de prostate et présentant première ou une nouvelle une récidive biologique (Nadir du PSA + 2 ng/ml ; confirmé sur deux prélèvements espacés d’une semaine) OU patients naïfs d’hormonothérapie traités par chirurgie ou radiothérapie externe pour un adénocarcinome de prostate mais avec maladie biologique persistante (PSA détectable après prostatectomie, ou PSA inchangé ou en progression après radiothérapie externe);
    I3. Bilan diagnostique de récidive par IRM pelvienne négatif, ou ayant mis en évidence une récidive locale ou des oligométastases pelviennes pouvant relever d’une irradiation externe ;
    I4. Consentement éclairé signé.
    E.4Principal exclusion criteria
    E1. Patient already treated by hormonotherapy;
    E2.Formal contraindication to hormonotherapy;
    E3. Formal contraindication to radiation therapy;
    E3. Formal contraindication to the Lasilix administration planned during the PET exams: Hypersensitivity to Furosemide or to one of the excipients, functional acute renal insufficiency, hepatic encephalopathy, urinary tracts obstruction, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia, hepatitis in evolution and severe hepatocellular insufficiency in haemodialysis and severe renal insufficiency (creatinine clearance <30 ml / min) due to the risk of accumulation of furosemide, which is then mainly eliminated by the biliary route;
    E4.Significant cardiovascular affection such as myocardial infarction within the last 6 months preceding inclusion, severe rhythm disturbances, stroke within 6 months prior to inclusion, prolonged corrected QT interval with QTc > 450 msecs according to Bazett formula;
    E5. Impossibility to comply with the study follow-up for geographical, social or psychic reasons.
    E1. Patient déjà sous hormonothérapie ;
    E2. Contre-indication formelle à l’hormonothérapie ;
    E3. Contre-indication formelle à la radiothérapie externe ;
    E4. Contre-indication formelle à l’administration de Lasilix® prévue lors des examens TEP : hypersensibilité au furosémide ou à l'un des excipients, insuffisance rénale aiguë fonctionnelle, encéphalopathie hépatique, obstruction sur les voies urinaires, hypovolémie ou déshydratation, hypokaliémie sévère, hyponatrémie sévère, hépatite en évolution et insuffisance hépatocellulaire sévère chez l'hémodialysé et l'insuffisant rénal sévère (clairance de la créatinine < 30 ml/min) en raison du risque d'accumulation du furosémide dont l'élimination se fait alors principalement par voie biliaire.
    E5. Affection cardiovasculaire significative de type :
     infarctus du myocarde dans les 6 mois précédant l’inclusion
     troubles du rythme graves
     accident vasculaire cérébral dans les 6 mois précédant l’inclusion
     allongement de l'intervalle QT corrigé (QTc) avec QTc > 450 msecs selon la formule de Bazett ;
    E6. Impossibilité de se soumettre au suivi de l’étude pour des raisons géographiques, sociales ou psychiques.
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the proportion of patients with positive PET in initial PET-PSMA (before androgen blockade) and H-PSMA-PET (=H-PSMA-PET after androgen blockade), patient being his own control.
    Comparaison de la proportion de patients présentant une TEP positive lors de la TEP-PSMA initiale (avant blocage androgénique) et de la TEP-PSMA-H (=TEP-PSMA après blocage androgénique), le patient étant son propre témoin
    E.5.1.1Timepoint(s) of evaluation of this end point
    Inclusion (before the androgen blockade) and Day 14 after the androgen blockade]
    A l'inclusion (avant le blocage androgenique) and J 14 après le blocage androgénique
    E.5.2Secondary end point(s)
    • Study of the inter-observer reproducibility of the interpretation of initial PET-PSMA and H-PSMA-PET on standard and late pelvic acquisitions.
    • Variation in the number of lesions and intensity of uptake (delta-SUVmax) of foci considered benign or suspicious according to interpretation guidelines between initial PET-PSMA and H-PSMA-PET.
    - Frequency and type of therapeutic management changes based on management questionnaires completed by two radiotherapists, separately, before and after PET-PSMA scans, but not knowing whether it was initial PET-PSMA or PET-PSMA-H.
    - Variation in the number of lesions and intensity of uptake (delta-SUVmax) of foci considered benign or suspicious according to interpretation guidelines, visualized on pelvic acquisition images at 3 hours of the 68Ga-PSMA injection compared to images at 1 hour on the same region of interest, for initial PET-PSMA and for H-PSMA-PET.
    - Correlation between the number of foci considered suspicious on each PET-PSMA scan and the clinical, histological data of the primary tumour and biological data of the recurrence (PSA kinetics and velocity calculated on https://www.mskcc.org/nomograms/prostate/psa_doubling_time).
    - Correlation of changes in PSA and testosterone levels with changes in the number and intensity of uptake of foci considered benign or suspicious between the two PET scans.
    - Toxicities evaluated according to the NCI-CTCAE v5 classification.

    Ancillary Study end point :
    -If the indication for external radiotherapy is maintained, evaluation of the variation in the number of lymph node areas and the overall volume to be irradiated between the two PET scans based initially only on the imaging results. This study will cover all the patients in the study and will be carried out by a nuclear physician and a Centre Léon Bérard radiotherapist.

    • Étude de la reproductibilité inter-observateur de l’interprétation de la TEP-PSMA initiale et de la TEP-PSMA-H sur les acquisitions standards et sur les acquisitions pelviennes tardives.
    • Variation du nombre de lésions et d’intensité de fixation (delta-SUVmax) des foyers considérés comme bénins ou suspects selon les guidelines d’interprétation14 entre la TEP-PSMA initiale et la TEP-PSMA-H.
    • Fréquence et type de modifications de prise en charge thérapeutique en se basant sur des questionnaires de prise en charge remplis par deux radiothérapeutes, séparément, avant et après TEP-PSMA mais sans savoir s’il s’agit de la TEP-PSMA initiale ou la TEP-PSMA-H.
    • Variation du nombre de lésions et d’intensité de fixation (delta-SUVmax) des foyers considérés comme bénins ou suspects selon les guidelines d’interprétation, visualisés sur les images d’acquisition pelvienne à 3 heures de l’injection du 68Ga-PSMA par rapport aux images à 1 heure sur la même région d’intérêt, pour la TEP-PSMA initiale et pour la TEP-PSMA-H.
    • Corrélation entre le nombre de foyers considérés comme suspects sur chaque TEP-PSMA et les données cliniques, histologiques de la tumeur primitive et biologiques de la récidive (cinétique et vélocité du PSA calculées sur https://www.mskcc.org/nomograms/prostate/psa_doubling_time).
    • Corrélation des variations des taux de PSA et de testostéronémie avec les variations de nombre et d’intensité de fixation des foyers considérés comme bénins ou suspects entre les deux TEP.
    • Toxicités évaluées selon la classification NCI-CTCAE v5.

    Critère de jugement de l’étude ancillaire :
    • En cas de maintien de l’indication de radiothérapie externe, évaluation de la variation du nombre d’aires ganglionnaires ainsi que du volume global à irradier entre les deux TEP en ne se basant dans un premier temps que sur les résultats d’imagerie. Cette étude portera sur l’ensemble des patients de l’étude et sera réalisée par un médecin nucléaire et un radiothérapeute du Centre Léon Bérard.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For all end points except toxicities : 1st PET-PSMA before androgen blockade and Day 14 after androgen blockade = H-PSMA-PET

    For toxicity: Inclusion until D15-D30 visit
    Pour tous les critères sauf l'évaluation de la toxicité:
    1ère TEP-PSMA (avant le blocage androgénique) et J14 après le blocage: TEP-PSMA-H
    Concernant la toxicité: de l'inclusion jusqu'à la visite de J15-J30
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 No
    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
    Dernière visite du dernier patient inclus dans l'étude
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state52
    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)
    At the physician discretion
    A la discrétion du médecin
    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 Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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