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    Summary
    EudraCT Number:2019-003483-43
    Sponsor's Protocol Code Number:PersonaLymPCa
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-14
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-003483-43
    A.3Full title of the trial
    Phase II Safety and Efficacy of personalized lymphadenectomy or guided by Indocyanine Green (IGC) vs extended pelvic lymph node dissection in patients diagnosed with Prostate Cancer subsidiaries of Radical Prostatectomy and lymphadenectomy
    Fase II. Seguridad y Eficacia de la linfadenectomía personalizada o guiada por Verde de Indocianina (IGC) vs la Linfadenectomía pélvica ampliada en pacientes diagnosticados de Cáncer de Próstata subsidiarios de Prostatectomía Radical y linfadenectomía.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Safety and Efficacy of personalized lymphadenectomy or guided by Indocyanine Green (IGC) vs extended pelvic lymph node dissection in patients diagnosed with Prostate Cancer subsidiaries of Radical Prostatectomy and lymphadenectomy
    Fase II. Seguridad y Eficacia de la linfadenectomía personalizada o guiada por Verde de Indocianina (IGC) vs la Linfadenectomía pélvica ampliada en pacientes diagnosticados de Cáncer de Próstata subsidiarios de Prostatectomía Radical y linfadenectomía.
    A.3.2Name or abbreviated title of the trial where available
    PersonaLymPCa
    PersonaLymPCa
    A.4.1Sponsor's protocol code numberPersonaLymPCa
    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 SponsorGrupo de Investigación en Tumores Uro-oncológicos
    B.1.3.4CountrySpain
    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 supportGrupo en Investigación en Tumores Uro-oncologicos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo de Investigación en Tumores Uro-oncológicos
    B.5.2Functional name of contact pointPresidente
    B.5.3 Address:
    B.5.3.1Street AddressBeltrán Báguena, 8
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46009
    B.5.3.4CountrySpain
    B.5.4Telephone number0034961114030
    B.5.5Fax number0034961114030
    B.5.6E-mailramirezfivo@gmail.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraprostatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINDOCYANINE GREEN
    D.3.9.1CAS number 3599-32-4
    D.3.9.3Other descriptive nameINDOCYANINE GREEN
    D.3.9.4EV Substance CodeSUB14208MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    We want to study the relationship between the extent of lymphadenectomy and surgical complications.
    Queremos estudiar la relación entre la extensión de la linfadenectomía y las complicaciones quirúrgicas.
    E.1.1.1Medical condition in easily understood language
    intermediate or high risk prostate cancer
    cáncdr de próstata de riesgo intermedio o alto
    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 10070467
    E.1.2Term Pelvic lymphadenectomy
    E.1.2System Organ Class 100000004865
    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 LLT
    E.1.2Classification code 10068478
    E.1.2Term Sentinel lymphadenectomy
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate that selective lymphadenectomy of the nodes stained with indocyanine green decreases the risk of complications
    Demostrar que la linfadenectomía selectiva de los ganglios teñidos con verde de indocianina disminuye el riesgo de complicaciones
    E.2.2Secondary objectives of the trial
    To determine whether lymph node dissection of the ICG-stained nodes has an equivalent capacity to stage patients diagnosed with PC subsidiary of radical prostatectomy and lymph node dissection.
    To demonstrate that selective lymphadenectomy has an equivalent cytoreductive ability.
    Determinar si la disección de ganglios linfáticos de los ganglios teñidos con ICG tiene una capacidad equivalente para estadificar a los pacientes diagnosticados con PC subsidiaria de prostatectomía radical y disección de ganglios linfáticos.
    Demostrar que la linfadenectomía selectiva tiene una capacidad citorreductora equivalente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men diagnosed with prostate cancer, over 18 years of age, subsidiaries of treatment with PR who wish to participate in the study and are trained to sign informed consent.
    Intermediate and high clinical risk CP according to the classification of the NCCN guidelines.
    Score of the Eastern Cooperative Oncology Group ECOG = 0 at the time of diagnosis of prostate cancer.
    ASA, I, II or III score
    Varones diagnosticados de cáncer de próstata (CP), mayores de 18 años, subsidiarios de tratamiento con PR que deseen participar en el estudio y estén capacitados para firmar el consentimiento informado.
    CP de riesgo clínico intermedio y alto según la clasificación de las guias NCCN.
    Puntuación de la Eastern Cooperative Oncology Group ECOG=0 en el momento del diagnóstico de cáncer de próstata.
    Puntuación ASA, I, II o III
    E.4Principal exclusion criteria
    • Androgen deprivation therapy prior to surgery. The use of finasteride or Dutasteride is allowed.
    • Body mass index greater than 40
    • Very low, low and very high risk groups.
    • Another tumor, excluding the basocellular or spinocellular of the dermis. If other tumors are allowed if the patient is> 2 years free of disease. .
    • History of major surgery of the rectum or sigma.
    • Active diverticulitis.
    • Psychological alterations, or family, sociocultural or geographical conditions that - in the opinion of the researcher - prevent the patient from completing the study.
    • Radiation therapy treatment, previous brachytherapy. If focal treatment is allowed prior to the indication of radical prostatectomy.
    • Terapia de deprivación androgénica previa a la cirugía. Se permite el uso de finasteride o Dutasteride.
    • Índice de masa corporal mayor a 40
    • Grupos de riesgo muy bajo, bajo y muy alto.
    • Otro tumor, exluyendo los basocelulares o espinocelulares de la dermis. Si se permite otros tumores si el paciente está >2 años Libre de enfermedad. .
    • Historia de cirugía mayor del recto o sigma.
    • Diverticulitis activa.
    • Alteraciones psicológicas, o condiciones familiares, socioculturales o geográficas que – a juicio del investigador- impidan al paciente completar el estudio.
    • Tratamiento con radioterapia, braquiterapia previa. Si se permite el tratamiento focal previo a la indicación de prostatectomía radical.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of Complications (any)
    Porcentaje de complicaciones (cualquiera)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 weeks
    12 weeks
    1 year
    6 weeks
    12 weeks
    1 year
    E.5.2Secondary end point(s)
    % of grade 3 complications.
    % of patients staged as pN1.
    Absolute number of metastatic nodes in each group.
    Number of ganglia dissected by gripo
    Ratio no. of metastatic nodes / no. of absolute nodes
    % of patients with PSA <= 0.01 at 3 months
    % of patients with PSA <= 0.01 at 12 months after the intervention.
    % of patients with PSA <= 0.01 24 months after the intervention.
    Time to use androgen deprivation therapy
    % of patients with androgenic deprivation at 2 years.
    Time to biochemical recurrence (PSA> 0.2 in two consecutive measurements separated from each other 2 weeks)
    % of patients in bichemical recurrence at two years (PSA> 0.2 in two consecutive measurements separated from each other 2 weeks).
    Grams in the 24 hours pad test at 3, 6 and 12 months
    % of pad-free patients 3, 6 and 12 months.
    % of patients who have required anti-incontinence surgery after 24 months of follow-up.
    IIEF5 Score at 3, 12 and 24 months.
    ICIQ-SF Score
    o % de complicaciones grado 3.
    o % de pacientes estadiados como pN1.
    o Nº absoluto de ganglios metastásicos en cada grupo.
    o Nº de ganglios disecados por gripo
    o Ratio nº de ganglios metastásicos/nº de ganglios absoluto
    o % de pacientes con PSA<= 0,01 a los 3 meses
    o % de pacientes con PSA<= 0,01 a los 12 meses de la intervención.
    o % of patients with PSA <= 0,01 a los 24 meses de la intervención.
    o Tiempo al uso de terapia de deprivación androgénica
    o % de pacientes con deprivación androgénica a los 2 años.
    o Tiempo a la recidiva bioquímica (PSA>0,2 en dos mediciones consecutivas separadas entre sí 2 semanas)
    o % de pacientes en recidiva biquímica a los dos años (PSA>0,2 en dos mediciones consecutivas separadas entre sí 2 semanas).
    o Gramos en el test de la compresa de 24 horas a los 3, 6 y 12 meses
    o % de pacientes libres de compresa a los 3, 6 y 12 meses.
    o % de pacientes que han requerido cirugía antiincontiencia a los 24 meses de seguimiento.
    o Puntuación IIEF5 a los 3, 12 y 24 meses.
    Puntuación ICIQ-SF
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 weeks
    12 weeks
    6 months
    1 year
    2 years
    5 years
    3 semanas
    12 semanas
    6 meses
    1 año
    2 año
    5 año
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Linfadenectomía ampliada
    Extended lymphadenectomy
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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
    Last visit of the last participant (LVLS)
    Última visita del último paciente reclutado
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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: 70
    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.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 use of further treatments will conform to the criteria of the researcher and the recommendations of the European urology guidelines. They must also be approved by the Institution´s multidisciplinary board.
    El uso de tratamientos adicionales se ajustará a los criterios del investigador y las recomendaciones de las guías europeas de urología. También deben ser aprobados por el consejo multidisciplinario de la institución.
    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 Decision2020-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-18
    P. End of Trial
    P.End of Trial StatusOngoing
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