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    Summary
    EudraCT Number:2020-004991-16
    Sponsor's Protocol Code Number:tba
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-24
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004991-16
    A.3Full title of the trial
    177Lu-PSMA RADIOLIGAND THERAPY IN PATIENTS WITH LYMPH NODE METASTATIC HORMONE-SENSITIVE PROSTATE CANCER UNDERGOING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    177Lu-PSMA RADIOLIGAND THERAPY IN PATIENTS WITH LYMPH NODE METASTATIC HORMONE-SENSITIVE PROSTATE CANCER UNDERGOING ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY AND EXTENDED PELVIC LYMPH NODE DISSECTION
    A.3.2Name or abbreviated title of the trial where available
    SHEPHERD trial
    A.4.1Sponsor's protocol code numbertba
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 nameLu-PSMA-I&T
    D.3.4Pharmaceutical form Injection/infusion
    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 INNLu-PSMA-I&T
    D.3.9.3Other descriptive namePSMA I&T
    D.3.9.4EV Substance CodeSUB199344
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.4
    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 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
    prostate cancer, eligible for radical prostatectomy and extended pelvic lymph node dissection, with 1-3 pelvic nodal metastases on preoperative PSMA PET
    E.1.1.1Medical condition in easily understood language
    prostate cancer, eligible for radical prostatectomy and extended pelvic lymph node dissection, with 1-3 pelvic nodal metastases on preoperative PSMA PET
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    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 investigate if surgery is feasible and safe in patients with newly diagnosed lymph node metastatic HSPCa (1-3 metastases; miN1) who have received two cycles of (neo-adjuvant) systemic 177Lutetium (Lu)-labeled prostate-specific membrane antigen (PSMA) radioligand therapy (RLT).
    E.2.2Secondary objectives of the trial
    • To investigate the therapeutic effect of two cycles of 177Lutetium (Lu)-labeled prostate-specific membrane antigen (PSMA) radioligand therapy (RLT) on histopathological variables in the resected prostate gland and lymph-nodes, in patients with newly diagnosed lymph node-positive (1-3 metastases) HSPCa.

    • To study the tolerability (toxicity) of study medication.

    • To assess the quality of life (QoL) by patient reported outcome measures (PROMS) and specific QoL questionnaires using the EORTC Quality of Life Questionnaire for cancer patients (EORTC-QLQC30 and EORTC-QLQ-PR25) [26,27] and the xerostomia inventory at baseline and at two weeks after each cycle of 177Lu-PSMA RLT.

    • To assess the prostate-specific antigen (PSA) free survival at 12 months after two cycles of 177Lu-PSMA RLT and concurrent RARP and ePLND.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men over 18 years of age
    - ECOG performance score (PS) 0-1
    - Histologically proven adenocarcinoma of the prostate cancer of any grade and/or stage
    - Any prostate-specific antigen (PSA)-level
    - Planned to undergo radical prostatectomy (RARP) and extended pelvic lymph node dissection (ePLND)
    - A pre-operative [68Ga] or [18F] PSMA PET/CT positive for lymphogenic metastatic disease (1-3 metastases; miN1) in the surgical template with a maximum of 6 weeks before study entry
    - An mpMRI of the abdomen with a maximum of 12 weeks before study entry
    - Deemed clinically fit for 177Lu-PSMA RLT
    - eGFR ≥ 30 mL/min/1.73 m2
    - Hemoglobin (Hb) ≥ 5.6 mmol/L
    - Leucocytes ≥ 3.0 x 109/L
    - Thrombocytes ≥ 100 x 109/l
    - Provided informed consent
    E.4Principal exclusion criteria
    - Previous treatment with any of the following within 6 months of inclusion:
    Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
    - Previous PSMA-targeted radioligand therapy
    - Any systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of inclusion
    - Known hypersensitivity to the components of the study therapy or its analogs
    - Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
    - Patients with signs of M1a-b-c disease on pre-operative PSMA PET/CT
    - Prior systemic hormonal therapy (ADT)
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is the surgical feasibility and safety of patients with newly diagnosed lymph node metastatic HSPCa who have received two cycles of (neo-adjuvant) systemic 177Lutetium (Lu)-labeled prostate-specific membrane antigen (PSMA) radioligand therapy (RLT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    t=12 weeks, at surgery
    E.5.2Secondary end point(s)
    1. the therapeutic effect of 177Lu-PSMA RLT on histopathological variables in the resected prostate gland and the resected pelvic lymph nodes,
    2. the assessment of the tolerability (toxicity) of 177Lu-PSMA RLT,
    3. the assessment of the quality of life (QoL) and well-being of patients receiving 177Lu-PSMA RLT and
    4. the PSA progression-free survival at 12 months after 177Lu-PSMA RLT and radical surgery.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: t=12 weeks, at surgery
    2=3: t=4 and t=10 weeks
    4: t=64 weeks after inclusion (12 + 52)
    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) 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.8.5The 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
    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 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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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.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)
    None
    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 Decision2022-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-23
    P. End of Trial
    P.End of Trial StatusOngoing
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