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    Summary
    EudraCT Number:2010-021900-93
    Sponsor's Protocol Code Number:CLIN1001PCM301
    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:2012-03-29
    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 number2010-021900-93
    A.3Full title of the trial
    A European Randomised Phase 3 Study to Assess the Efficacy and Safety of TOOKAD Soluble for Localised Prostate Cancer Compared to Active Surveillance
    Studio europeo randomizzato di Fase 3 eseguito per valutare l'efficacia e la sicurezza di TOOKAD Soluble nel trattamento del tumore della prostata localizzato rispetto alla sorveglianza attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A European study to assess the Efficacy and Safety of TOOKAD Soluble for patients with localised prostate cancer selected at random for either treatment with the study drug or for active surveillance
    Uno studio europeo eseguito per valutare l’efficacia e la sicurezza di TOOKAD Soluble nei pazienti con tumore localizzato selezionati in modo casuale per il trattamento con il farmaco in studio o per la sorveglianza attiva
    A.4.1Sponsor's protocol code numberCLIN1001PCM301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01310894
    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 SponsorSTEBA BIOTECH
    B.1.3.4CountryLuxembourg
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSteba Biotech
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSteba Biotech
    B.5.2Functional name of contact pointInternational Project Leader
    B.5.3 Address:
    B.5.3.1Street Address7 Place du Theatre
    B.5.3.2Town/ cityLuxembourg
    B.5.3.3Post codeL-2613
    B.5.3.4CountryLuxembourg
    B.5.4Telephone number+352 26 10 22 95
    B.5.5Fax number+352 26 10 23 95
    B.5.6E-mailb.gaillac@stebabiotech.com
    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 nameTOOKAD Soluble
    D.3.2Product code WST11
    D.3.4Pharmaceutical form Powder for 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 INNPadeliporfin
    D.3.9.1CAS number 886845-72-3
    D.3.9.2Current sponsor codeWST11
    D.3.9.3Other descriptive namePalladium Bacteriopheophorbide Monolysotaurine
    D.3.9.4EV Substance CodePRD173962
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400.2
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typesmall-molecule pharmaceutical drug
    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
    Localised prostate cancer
    Tumore alla prostata localizzato
    E.1.1.1Medical condition in easily understood language
    Localised prostate cancer
    Tumore alla prostata localizzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of TOOKAD Soluble VTP on the rate of absence of definite cancer using patients on active surveillance as a comparison (co-primary objective A). To determine the difference in rate of treatment failure associated with observed progression of disease from low risk prostate cancer to moderate or higher risk prostate cancer in men who undergo TOOKAD Soluble VTP compared to men on Active Surveillance (co-primary objective B).
    Valutare l’impatto della VTP con TOOKAD Soluble sulla percentuale di assenza di tumore facendo il confronto con pazienti soggetti a sorveglianza attiva (obiettivo co-primario A). Determinare la differenza di percentuale di fallimento del trattamento associato all’osservazione del progredire della malattia da tumore della prostata a basso rischio a tumore della prostata a rischio moderato o alto in pazienti sottoposti a VTP con TOOKAD Soluble rispetto a pazienti sottoposti a sorveglianza attiva (obiettivo co-primario B).
    E.2.2Secondary objectives of the trial
    To determine the differences between men who undergo TOOKAD Soluble VTP and men on active surveillance with regard to: • the rate of additional prostate cancer radical therapy • the total cancer burden in the prostate • the rate of adverse events • the rate of incontinence, erectile dysfunction, urinary symptoms • the rate of severe prostate cancer related events: cancer extension T3, metastasis and prostate cancer related death. The overall quality of life will be recorded for potential utility and descriptive studies.
    Determinare le differenze tra pazienti sottoposti a VTP con TOOKAD Soluble e pazienti sottoposti a sorveglianza attiva relativamente a quanto segue: • la percentuale di terapia radicale aggiuntiva nel tumore della prostata • l’incidenza totale del tumore della prostata • la percentuale di eventi avversi • la percentuale di incontinenza, disfunzione erettile e sintomi urinari • la percentuale di eventi severi legati al tumore alla prostata: estensione del tumore a T3, metastasi e decesso legato al tumore della prostata La qualita' globale della vita verra' registrata a scopo di potenziale utilizzo e per gli studi descrittivi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Low risk prostate cancer diagnosed with one existing transrectal ultrasound guided biopsy(TRUST) using from 10 to 24 cores performed then 6 months prior to enrolment and showing the following using either: : • Gleason 3 + 3 prostate adenocarcinoma as a maximum, • Two (2) to three (3) cores positive for cancer, • A maximum cancer core length of 5 mm in any core, 2) Cancer clinical stage up to T2a (pathological or radiological up to T2c disease permitted), 3) Serum prostate specific antigen (PSA) of 10 ng/mL or less, 4) Prostate volume equal to or greater than 25 cc and less than 70 cc, 5) Male subjects aged 18 years or older.
    1) Tumore della prostata a basso rischio diagnosticato con una biopsia mediante ecografia prostatica trans rettale (TRUST)con l` utilizzo da 10 a 24 core risalente a meno di 6 mesi dall` arruolamento e indicando quanto segue : • Gleason 3 + 3 adenocarcinoma prostatico come livello massimo, • Da due (2) a tre (3) core positivi al tumore • Una lunghezza massima del core tumorale di 5 mm in qualsiasi core. 2) Fase clinica del tumore fino a T2a (patologico o radiologico fino a T2c ammesso) 3) Antigene prostatico specifico (PSA) pari a 10 ng/mL o inferiore 4) Volume prostatico uguale o superiore a 25 cc e inferiore a 70 cc. 5) Soggetti maschi di 18 anni di eta' o superiore.
    E.4Principal exclusion criteria
    1) Unwillingness to accept randomisation to either of the two arms of the study 2) Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy) or chemotherapy. 3) Life expectancy less than 10 years. 4) Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure. 5) Participation in another clinical study or recipient of an investigational product within 1 month of study entry.6) Subject unable to understand the patient's information document, to give consent or complete study tasks. Subject in custody or in residence in a nursing home or rehabilitation facility. 7) Contra-indication to MRI (e.g., pacemaker, history of allergic reaction to gadolinium), or factors excluding accurate reading of pelvic MRI (e.g., hip prosthesis).
    1)Rifiuto ad accettare la randomizzazione in uno o l’altro dei due bracci dello studio 2)Precedenti o attuali trattamenti per il tumore della prostata compresi intervento chirurgico, radioterapia (esterna or brachiterapia) o chemioterapia. 3)Aspettativa di vita inferiore a 10 anni. 4) Eventuali condizioni o malattie o interventi suscettibili di rappresentare un rischio supplementare per i pazienti sottoposti a VTP. 5)Partecipazione a un altro studio clinico o destinatario di un prodotto in fase di sperimentazione entro 1 mese dall’inizio della partecipazione allo studio. 6) Soggetto incapace di comprendere il documento informativo del paziente, di dare il suo consenso o di completare gli incarichi dello studio. Soggetto sotto custodia o ricoverato in casa di cura o in una struttura riabilitativa 7)Controindicazioni alla MRI (ad es. pacemaker, reazioni allergiche al gadolinio) o fattori che escludano una lettura accurata della MRI pelvica (ad es. protesi dell’anca).
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoint `A` Absence of any histological result definitely positive for cancer. Co-primary endpoint `B` Failure of treatment due to progression of cancer from low to moderate or higher risk over the 24 month follow- up. Moderate or higher risk is defined as the observation of: • More than 3 cores positive for cancer when considering all histological examination available during follow-up of study; • or any Gleason primary or secondary pattern 4 or more; • or at least one cancer core length greater than 5 mm; • or PSA>10ng/mL in 3 consecutive measures; • or any T3 prostate cancer; • or metastasis; • or prostate cancer related death.
    End-point primario End-point co-primario ‘A’ Assenza di esiti istologici positivi al tumore End-point co-primario ‘B’ Fallimento del trattamento dovuto alla progressione del tumore da rischio basso a moderato o alto nel periodo di follow-up di 24 mesi. Il rischio moderato o alto e' definito dall’osservazione di quanto segue: - Oltre 3 core positivi al tumore prendendo in considerazione tutti gli esami istologici disponibili durante il periodo di follow-up dello studio; - o pattern di Gleason 4 primari o secondari o superiori; - o almeno una lunghezza del core del tumore maggiore di 5 mm; - o PSA>10ng/mL ( in 3 misurazioni consecutive); - o tumore della prostata T3, - o metastasi; - o decesso legato al tumore della prostata
    E.5.1.1Timepoint(s) of evaluation of this end point
    Histological changes are assessed using 12-core TRUS biopsies or a density of 1 core per 2 cc of prostate tissue in case of significant prostate shrinking has occurred, performed at 12 months (+/- 2 months) and using saturated TRUS biopsy of 1 core per 2 cc (up to 24 cores) at 24 months or any other pathology result obtained during the study planned or not. The follow-up is done to loss to follow-up, early study termination or 24 months after randomisation, whatever the treatment events occurring (drop-out, radical treatment).
    I cambiamenti istologici sono valutati mediante biopsie TRUS a 12 core, o con la densita' di 1 core per 2 cc di tessuto prostatico qualora si sia verificato un significativo restringimento della prostata, eseguite a 12 mesi (+/- 2 mesi) e utilizzando la biopsia TRUS a saturazione di 1 core per 2 cc (fino a 24 core) a 24 mesi o altri eventuali esiti patologici ottenuti durante lo studio pianificato o meno. Il follow-up viene effettuato fino a quando i pazienti non sono persi al follow up, fino alla conclusione precoce dello studio o 24 mesi dopo la randomizzazione, qualunque siano gli eventi del trattamento che si sono verificati (drop-out, trattamento radicale).
    E.5.2Secondary end point(s)
    - Notification of initiation of radical therapy - Total number of cores positive for cancer - Patients’ reported outcome measures (PROMs) impairment: urinary symptoms, erectile functions - Adverse event reporting - Severe prostate cancer related events: cancer extension to T3, metastasis or prostate cancer-related death Quality of life will also be described.
    - Comunicazione di inizio di terapia radicale - Numero totale di core positivi al tumore - Peggioramento dei patients’ reported outcome (PROM) dei pazienti, ossia gli indicatori di risultato espressi dai pazienti: sintomi urinari, funzioni erettili - Segnalazione di eventi avversi - Eventi gravi legati al tumore della prostata: estensione del tumore a T3, metastasi o decesso connesso al tumore della prostata La qualita' della vita sara' ugualmente descritta.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    sorveglianza attiva
    Active surveillance
    E.8.2.4Number of treatment arms in the trial2
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    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.1.1Number of subjects for this age range: 0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 400
    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)
    Patients will be treated as standard of care after their study participation. During the study, there is the option of retreatment.
    I pazienti riceveranno il trattamento standard. Durante lo studio c`e' la possibilita' di essere ritrattati.
    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 Decision2011-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-25
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