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    Summary
    EudraCT Number:2020-000076-37
    Sponsor's Protocol Code Number:NL72585.091.20
    National Competent Authority:Cyprus - MoH-Ph.S
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-03-29
    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 ConcernedCyprus - MoH-Ph.S
    A.2EudraCT number2020-000076-37
    A.3Full title of the trial
    Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lutetium-177-PSMA therapy in metastatic prostate cancer.
    A.3.2Name or abbreviated title of the trial where available
    Bullseye-2
    A.4.1Sponsor's protocol code numberNL72585.091.20
    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 SponsorRadboud University Medical Center
    B.1.3.4CountryNetherlands
    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 supportProstaatkankerstichting Nederland
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportRadboud Oncologie Fonds
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportAdvanced Accelarator Applications International SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointMedical Imaging research office
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailMichel.deGroot@radboudumc.nl
    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 Pluvicto 1 000 MBq/mL solution for injection/infusion
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePluvicto 1 000 MBq/mL solution for injection/infusion
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    Oligo-metastatic adenocarcinoma of the prostate.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer.
    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
    The main objective of this study is to assess the difference in the fraction
    of patients with low volume, hormone sensitive metastatic PCa that
    meet EOT 1 criteria after 177Lu-PSMA RLT compared to those that have
    a deferred androgen deprivation treatment schedule.
    EOT 1 is defined by:
    - Clinical progression determined by the treating physician (e.g.
    increasing pain from metastases)
    - A 100% increase in PSA after cycle one blood draw (BASELINE) during
    study. Exception: PSA increase in the first 12 weeks after the first
    treatment injection as was defined by the PCWG3 criteria.
    E.2.2Secondary objectives of the trial
    - To assess ADT free survival in patients receiving 177Lu-PSMA RLT. ADT
    free survival is defined by the date ADT is started or death related to
    PCa.
    - To evaluate the clinical efficacy of multiple doses 177Lu-PSMA
    radioligand therapy in patients with low volume, hormone sensitive
    metastatic PCa.
    - To assess progression free survival, defined as from the time frominclusion to date of evidence of: clinical progression, death from any
    cause, PSA progression, or radiographic progression, whichever occurs
    first.
    - To evaluate the tolerability and toxicity of 177Lu-PSMA RLT defined by
    NCI Common Terminology Criteria for Adverse Events v5.0.
    - To evaluate the quality of life before and up to 6 months after 177Lu-
    PSMA RLT using the following questionnaires: EORTC QLQ-C30, QLQPR25
    & xerostomia inventory.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histological proven adenocarcinoma of the prostate with archived
    tumor material.
    - Biochemical recurrence or clinical progression (PSA > 1.0 μg/l).
    - ECOG 0-1.
    - PSA-doubling time < 6 months.
    - 18F-PSMA-PET-CT positive metastases in bones and/or lymph nodes
    (N1/M1ab): ≥1, maximally 5 metastases .
    - Local treatment for oligometastases with radiotherapy or surgery
    appears to be no option anymore (due to prior treatment or the location
    of the metastatic lesions).
    - No prior hormonal therapy (including any androgen directed treatment
    such as Bicalutamide, Apalutamide, Abiraterone or Enzalutamide) or
    taxane based chemotherapy (docetaxel or cabazitaxel); testosterone >
    1.7 nmol/l.
    Exception: local prostate cancer treated with local radiotherapy plus
    adjuvant ADT; these patients need to be stopped with ADT at least 6
    months.
    - No visceral metastases.
    - Laboratory values:
    • White blood cells > 3.0 x 109/l
    • Platelet count > 75 x 109/l
    • Hemoglobin > 6.2 mmol/l
    • ASAT, ALAT < 3 x ULN
    • MDRD-GFR ≥ 50 ml/min
    - Signed informed consent.
    E.4Principal exclusion criteria
    - A detectable lesion on the 18F-PSMA PET/CT with significant PSMA
    avidity, defined by a SUVmax > 10 (partial volume corrected).
    - A known subtype other than prostate adenocarcinoma.
    - Previous PSMA based radioligand treatment.
    - Visceral or brain metastases.
    - Any medical condition present that in the opinion of the investigator
    will affect patients' clinical status when participating in this trial.
    - Prior hip replacement surgery potentially influencing performance of
    PSMA PET/CT.
    - Sjogren's syndrome.
    - A second active malignancy other than prostate cancer.
    - Patients who are sexually active and not willing/able to use medically
    acceptable forms of barrier contraception.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the difference in the fraction of patients that have disease
    progression during the 6 month follow up of this study after 177Lu-PSMA
    RLT or a deferred androgen deprivation treatment schedule.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End-of-Study (Week 24).
    E.5.2Secondary end point(s)
    - ADT-free survival.
    - PSA response.
    - Toxicity based on NCI CTCAE v5.0 criteria.
    - Radiological state of the disease, expressed in the difference in amount
    and size of suspicious nodes on 18F-PSMA PET/CT and (whole body) MRI
    between pre- and post-therapy.
    - Quality of Life assessments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During study and up to End-of-Study (Week 24).
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Best standard-of care.
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years2
    E.8.9.1In the Member State concerned months6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 58
    F.4.2.2In the whole clinical trial 58
    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)
    Resume best standard-of-care.
    Hervatten van de standaard zorg.
    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 Decision2023-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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