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    EudraCT Number:2014-002833-70
    Sponsor's Protocol Code Number:s56892
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-01
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-002833-70
    A.3Full title of the trial
    Radium-223 in patients with PSA progression and without clinical
    metastases following maximal local therapy: a pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radium-223 in patients with PSA progression and without clinical
    metastases following maximal local therapy: a pilot study
    A.4.1Sponsor's protocol code numbers56892
    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 SponsorUZLeuven
    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 supportBayer
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZLeuven
    B.5.2Functional name of contact pointClinical Trial Center (CTC)
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.4Telephone number003216341998
    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. name Xofigo
    D. of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameradium-223 dichloride
    D.3.4Pharmaceutical form 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Patients with prostate cancer (PCa) who experience PSA progression
    and who are without detectable metastases following maximal local
    treatment consisting of radical prostatectomy (RP) + pelvic
    lymphadenectomy (PLND) and external beam radiotherapy (EBRT), or
    who present only with biochemical relapse after salvage lymph node
    dissection. Among patients with PSA relapse, those at major risk of
    metastatic progression will be studied.
    E.1.1.1Medical condition in easily understood language
    Patients with prostate cancer (PCa) who experience PSA progression
    and who are without detectable metastases following maximal local
    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 assess the clinical safety/tolerability of Radium-223 treatment in
    patients affected by prostate cancer with biochemical relapse after
    maximal local treatment with high risk of metastatic progression. Safety
    and feasibility results could be used to plan an eventual phase II/III
    E.2.2Secondary objectives of the trial
    To assess biomarkers (PSA and bALP) and imaging progression to
    metastatic disease after Radium-223 treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following criteria to be enrolled in the study:
    1. Male aged 18 years or older with histological confirmation of prostatic adenocarcinoma.
    2. Ability to provide informed consent and demonstration of willingness to follow all study phases.
    3. Patient has to agree to use effective birth control method during and for 6 months after discontinuation of study treatment.
    4. Patient is experiencing biochemical progression according to the following definition:
    a. PSA >0.2 ng/ml following maximal local treatment consisting of RP and PLND and adjuvant or salvage EBRT
    b. PSA >0.2 ng/ml following maximal local therapy consisting of salvage LND in patients treated primarily by RP + PLND and adjuvant or
    salvage EBRT.
    5. Negative prognostic factors for metastatic progression.
    a. At least 1 of the risk factors should be present according to the
    following specific patient scenarios (for group at point 4a).
    • Salvage EBRT group (at least one of subsequent factors)
    - PSADT <12 months (postoperative PSA)
    - pT ≥3
    - pGS ≥8
    • Adjuvant EBRT group (at least one of subsequent factors):
    - pT ≥3 and pGS ≥8
    - pT ≥3 and detectable postoperative PSA
    - PSADT <12months (PSA post adjuvant EBRT)
    • pN1 (at least one of subsequent factors):
    - pGS ≥8
    - pT ≥3
    - ≥3 positive nodes
    - Positive surgical margins
    b. At least 1 of the risk factors should be present according to the
    following specific patient scenarios (for group at point 4b):
    • PSA≥0.2 ng/ml relapse within 40 days after salvage lymph node
    • Retroperitoneal lymph node positivity at salvage lymph node
    6. Absence of metastatic disease at Choline PET-CT, 18F-Fluoride PETCT and whole-body MRI.
    7. Adequate haematological, liver and renal function:
    • Absolute neutrophil count (ANC) ≥ 1.5 x109/l
    • Platelet count ≥ 100 x109/L
    • Hemoglobin ≥10.0 g/dl (100 g/l; 6.2 mmol/l)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    or Gilbert Syndrome without any other liver dysfunction.
    • Aspartate aminotransferase (AST) ≤ 2.5 x ULN
    • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Albumin > 25 g/l
    E.4Principal exclusion criteria
    Patients should not meet any of the following criteria:
    1. Previous (ADT stopped at least 6 months before screening is allowed
    and serum testosterone assay should be evaluated in these patients to
    exclude levels <20ng/dl. If testosterone levels have been demonstrated
    as ≥20ng/dl after interruption of ADT, further testosterone evaluations
    can be avoided) and ongoing systemic PCa therapies or other PCa
    investigational treatments including also 5-alpha reductase inhibitors,
    azole antifungal agents, corticoids, food supplements containing soy
    2. Radiotherapy to approximately >25% of bone marrow, including
    hemibody radiation.
    3. Bone systemic therapy.
    4. Other malignancy treated within the last 3 years.
    5. Have any contraindication to imaging diagnostic procedures (Choline
    PET-CT,18F- Fluoride PET-CT and whole-body MRI).
    6. Diagnosis of visceral and/or node and/or bone metastases at Choline
    PET-CT and/or 18F- Fluoride PET-CT and/or whole-body MRI.
    7. Any other serious illness or medical condition, such as but not limited to:
    - Any major infection
    - Cardiac failure New York Heart Association (NYHA) III or IV
    - Crohn's disease or ulcerative colitis
    - Bone marrow dysplasia
    - Fecal incontinence
    8. Medical condition or other elements that, in the investigator's opinion, could decrease the possibility to reach objectives of the study.
    9. ECOG performance status ≥2
    10. Life expectancy < 6 months
    E.5 End points
    E.5.1Primary end point(s)
    •Throughout the entire study, safety data will be collected as
    frequencies of different AE/SAE obtaining proportions of side effects in
    order to confirm tolerability patterns for the present study population.
    •Feasibility variables will be collected as: recruitment rates, consent
    rates, completion rates; completion of the study will test logistic,
    procedural and administrative feasibility.
    E.5.1.1Timepoint(s) of evaluation of this end point
    •Throughout the entire study, safety data will be collected: from the first
    visit before the first dose and then every 4 weeks before drug injection
    (for a total of 6 injections). Every 3 months for 4 visits after the last
    dose and thyen every 3 months until the end of the study.
    •Feasibility variables will be collected at the end of the study.
    E.5.2Secondary end point(s)
    evaluate PSA progression kinetics (median time to PSA progression).
    PSA progression is every confirmed (3 confirmatory PSA measurements,
    at least 1 week apart) PSA relapse with an increase superior to 50%
    from PSA nadir or confirmed PSA (3 confirmatory PSA measurements, at
    least 1 week apart) detectability when PSA became not more detectable.
    •bALP will be sampled during treatment and follow-up. bALP will be
    assessed as the proportion of patients who have biochemical values out
    of normality range. Time to bALP progression will be measured in order
    to better understand the bALP variations (median time to bALP
    progression) during the study.
    •Metastasis outbreak will be detected by medical imaging (Choline PETCT,
    18F-Fluoride PET-CT and whole-body MRI ) before treatment and
    follow up with a maximum number of 2 imaging sessions (screening
    E.5.2.1Timepoint(s) of evaluation of this end point
    •PSA will be assessed: from screening visit, at every visit time.
    •bALP will be assessed: from screening visit, at every visit time.
    •Metastasis outbreak will be detected by medical imaging (Choline PETCT,
    18F-Fluoride PET-CT and whole-body MRI ) before treatment and
    follow up ( at PSA progression or end of follow up).
    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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 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 Yes
    E. trial design description
    The study drug is going to be tested in a novel population.
    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.8.2.4Number of treatment arms in the trial1
    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 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
    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 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: 15
    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 state15
    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)
    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 Decision2014-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-06
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