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    EudraCT Number:2019-002957-46
    Sponsor's Protocol Code Number:56021927PCR3015
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-03-15
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2019-002957-46
    A.3Full title of the trial
    A Randomized, Controlled, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET, with an Observational Cohort
    Randomizované, kontrolované, multicentrické, odslepené skúšanie na preskúmanie účinnosti a bezpečnosti pridania apalutamidu k rádioterapii a agonistovi LHRH u vysokorizikových pacientov s hormonálne senzitívnym karcinómom prostaty hodnoteným pomocou PSMA-PET, s observačnou kohortou
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to assess the efficacy and safety of apalutamide in the treatment of high-risk Hormone-Sensitive Prostate Cancer assessed by an imaging scan.
    Klinické skúšanie hodnotiace účinnost a bezpečnosť apalutamidu pri liečbe vysoko rizikového homonálne senzitívneho karcinómu prostaty hodnoteného zobrazovacím vyšetrením
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number56021927PCR3015
    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 SponsorJanssen-Cilag International NV
    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 supportJanssen Pharmaceutica NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg, 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333
    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 nameApalutamide
    D.3.2Product code JNJ-56021927
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApalutamide
    D.3.9.1CAS number 956104-40-8
    D.3.9.2Current sponsor codeJNJ-56021927-AAA
    D.3.9.3Other descriptive nameAPALUTAMIDE
    D.3.9.4EV Substance CodeSUB127215
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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
    High risk recurrent prostate cancer previously treated with radical prostatectomy
    E.1.1.1Medical condition in easily understood language
    Recurrent prostate cancer previously treated with radical prostatectomy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036911
    E.1.2Term Prostate cancer recurrent
    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 determine if the addition of apalutamide to RT+LHRHa delays metastatic progression as assessed by PSMA-PET or death compared with RT+LHRHa alone.
    E.2.2Secondary objectives of the trial
    - To determine if the addition of apalutamide to RT+LHRHa provides superior efficacy in other efficacy endpoints compared with RT+LHRHa alone.
    - To characterize the safety profile of treatment with RT+LHRHa plus apalutamide.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Person, 18 years of age or older (or the legal age of consent in the jurisdiction in which the study is taking place).
    2 Signed an Informed Consent Form (ICF) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study; participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    3. Histologically confirmed adenocarcinoma of the prostate.
    4. Criterion changed per Amendment 1.
    4.1 Criterion changed per Amendment 2.
    4.2 Criterion changed per Amendment 3.
    4.3 Previously treated with radical prostatectomy with or without lymph node dissection and either
    a)For Biochemical recurrence after RP: Any post-operative PSA measurement of <0.1 ng/mL within 12 months after RP and without any PSA ≥0.1 ng/mL within the 4 to 8-week period after RP. OR
    b)For persistent PSA after RP: PSA ≥0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later.
    5. Criterion deleted per Amendment 2
    6. Criterion changed per Amendment 1.
    6.1 Criterion changed per Amendment 2.
    6.2 Criterion changed per Amendment 3.
    6.3 High risk of developing metastasis defined as:
    a) For biochemical recurrence after RP: pathological Gleason score ≥8, evaluated from prostate tissue specimen at radical prostatectomy, OR PSADT ≤12 months at the time of screening.
    b) For persistent PSA after RP: Pathological Gleason score ≥8, evaluated from prostate tissue specimen at radical prostatectomy
    7. Criterion changed per Amendment 1.
    7.1 Criterion changed per Amendment 3.
    7.2 Results of PSMA-PET at screening , as determined by BICR, must be:
    - PSMA-PET-negative for any prostate cancer lesions (ie, no locoregional lesion and no distant lesions); OR
    - PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra pelvic lesion OR
    - PSMA-PET-positive for at least one loco-regional (pelvic) lesion with distant extra-pelvic lesion(s)
    8. Criterion changed per Amendment 1.
    8.1 Criterion changed per Amendment 2.
    8.2 Criterion changed per Amendment 3.
    8.3 Patients with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, 99m Tc whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the patient should be excluded from the study. Conventional images (99mTc bone scan and CT/MRI) from screening will be evaluated locally before randomization.
    9. Eastern Cooperative Oncology Group Performance Status Grade 0 or 1.
    10. Criterion changed per Amendment 1.
    10.1 Adequate organ function as defined by the following criteria:
    - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 X upper limit of normal (ULN) and total bilirubin ≤1.5 x ULN.
    - Serum creatinine <1.8 mg/dL.
    - Platelets ≥75,000/µL, without transfusion and/or growth factors within 1 month prior to randomization.
    - Hemoglobin ≥10.0 g/dL (6.21 mmol/L), without transfusion and/or growth factors within 1 month prior to randomization.
    11. Criterion changed per Amendment 1.
    11.1 Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce.
    12. Criterion changed per Amendment 1.
    12.1 If the participant engages in sexual activity with a person of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 3 months after the last dose of study drug.
    13. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum 3 months after receiving the last dose of study drug.
    14. Criterion added per Amendment 1.
    Participants receiving bone-loss prevention treatment with bone-sparing agents indicated for the treatment of osteoporosis at doses and dosing schedules appropriate for the treatment of osteoporosis (eg, denosumab [Prolia®], zoledronic acid [Reclast®]) must be on stable doses for at least 4 weeks before randomization.
    15.Criterion added per Amendment 2.
    Participant is indicated and planned to receive whole pelvic SRT for BCR prostate cancer.
    E.4Principal exclusion criteria
    1. History of pelvic radiation for malignancy.
    2. Criterion deleted per Amendment 1.
    3. Previous treatment with ADT for prostate cancer.
    4. Criterion changed per Amendment 2.
    4.1 Previously treated for BCR or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed).
    5. Prior treatment with a CYP17 inhibitor (eg, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any AR antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (eg. estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy.
    6. Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate.
    7. Any of the following within 6 months prior to first dose of study treatment: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
    8. Use of 5-alpha-reductase inhibitor ≤4 weeks prior to randomization.
    9. Use of investigational agent ≤4 weeks prior to randomization.
    10. Not applicable; criterion numbering omitted from initial protocol in error.
    11. Prior chemotherapy for prostate cancer.
    12. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:
    - Non-muscle invasive bladder cancer.
    - Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
    - Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and considered to have a very low risk of recurrence.
    - Malignancy that is considered cured with minimal risk of recurrence.
    13. Human immunodeficiency virus-positive participants with 1 or more of the following:
    - Not receiving highly active antiretroviral therapy
    - Had a change in antiretroviral therapy within 6 months of the start of screening
    - Receiving antiretroviral therapy that may interfere with study treatment (consult Sponsor for review of medication prior to enrollment)
    - CD4 count <350 at screening
    - AIDS-defining opportunistic infection within 6 months of start of screening
    14. Chronic, active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction.
    15. History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
    16. Treatment with drugs known to lower the seizure threshold within 4 weeks prior to randomization.
    17. Known or suspected contraindications or hypersensitivity to apalutamide, LHRH agonist or any of the components of the formulations.
    18. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant.
    Plans to father a child while enrolled in this study or within 4 weeks after the last dose of study intervention.
    19. Criterion deleted per Amendment 1.
    20.Criterion added per Amendment 2.
    Any evidence of prostate cancer metastasis on CT/MRI of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    PSMA-PET metastatic progression-free survival (ppMPFS): Defined as the time from randomization to the (scan) date of metastatic progression by PSMA PET (as determined by BICR) or death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening, Month 6, Month 12, then annually until the end of the study. The frequency of PSMA PET assessments will increase as soon as participants reach PSA level ≥0.2 ng/mL a  PSMA-PET assessment will be  performed, and then every 6 months until PSMA-PET metastatic progression is confirmed or end of the study.
    E.5.2Secondary end point(s)
    - Time to PSA progression.
    - PSA response rate.
    - PSA levels at end of Week 26.
    - Time to loco-regional progression by PSMA-PET.
    - Overall survival and prostate cancer–specific survival.
    - Adverse events and serious adverse events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSA assessment will be every 3 months during the study until primary endpoint. Survival status will be documented throughout the study; when participants reach the primary end-point, survival status will be obtained via telephone calls.
    Sponsor has established Standard Operating Procedures in conformity with regulatory requirements worldwide to ensure appropriate reporting of safety information; this clinical study will be conducted in accordance with those procedures.
    If interim analysis of primary end point is not statistically significant, all endpoints will be evaluated at the end of study. If IA is statistically significant and will lead to early study termination then all endpoints will be evaluated at this point.
    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. 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 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. description
    Combination Therapy (RT(Radiotherapy)+LHRHa(Luteinizing Hormone-Releasing Hormone Agonist))
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Russian Federation
    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
    Once approximately 192 events are reached and approximately 9 years after first participant is enrolled unless the study is declared positive after the interim analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days11
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 No
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 412
    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)
    subsequent treatment is at investigator discretion
    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 Decision2021-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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