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    Summary
    EudraCT Number:2016-002854-19
    Sponsor's Protocol Code Number:S58827
    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:2017-05-11
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-002854-19
    A.3Full title of the trial
    Neoadjuvant degarelix +/- apalutamide (ARN-509) followed by radical prostatectomy for intermediate and high-risk prostate cancer: a randomized, placebo-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neoadjuvant degarelix +/- apalutamide (ARN-509) followed by radical prostatectomy for intermediate and high-risk prostate cancer: a randomized, placebo-controlled trial.
    A.4.1Sponsor's protocol code numberS58827
    A.5.4Other Identifiers
    Name:ClinicalTrial.govNumber:NCT03080116
    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 SponsorUZ Leuven
    B.1.3.4CountryBelgium
    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 supportJanssen Cilag NV
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportFerring Pharmaceutical
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven
    B.5.2Functional name of contact pointClinical Trial Center (CTC)
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat
    B.5.3.2Town/ cityLeuven
    B.5.3.4CountryBelgium
    B.5.6E-mailctc@uzleuven.be
    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 or ARN-509
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Firmagon
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    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 namedegarelix
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer
    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
    To assess the difference in treatment antitumor effect between the treatment arms by measuring pathological tumor volume following radical prostatectomy.
    E.2.2Secondary objectives of the trial
    To measure differences between study arms in:
    Proportions of post neoadjuvant PSA≤ 0.3 ng/ml as a predictor of prostate cancer mortality
    T down-staging, complete pathological response, PSA kinetics, Testosterone kinetics, operation time, blood loss, grade of surgical difficulty
    New generation hybrid imaging (68Ga PSMA PET/MR) derived parameters
    Early biochemical recurrence as prognostic factor of prostate cancer mortality
    Transcriptome and genome
    Tissue microarrays (TMA) protein expression (DNA repair, resistance etc.) by immunohistochemistry
    Perioperative safety and tolerability
    Quality of life, erection recovery, continence through validated preoperative and postoperative questionnaires pre and postop (IEEF5, ICIQ EORTC, QLQ-C30)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    2. Before patient registration/randomization, written informed consent must be attained according to ICH/GCP, and national/local regulations
    3. Male aged 18 years or older (within 80 years)
    4. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
    5. Diagnosis of intermediate prostate cancer (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic
    adenocarcinoma (clinical stage≥T2c and/or biopsy GS≥8 and/or PSA>20ng/ml), cN0-cN1, cM0.
    6. Patient amenable for radical prostatectomy + pelvic lymph node dissection by open or robotic approach.
    7. ECOG performance status: 0-1 (Appendix1)
    8. Adequate organ function as defined by the following criteria:
    - White blood cells (WBC) ≥ 4.0 x109/L
    - Platelet count ≥ 100 x109/L
    - Hemoglobin ≥ 9.0 g/dl
    - Creatinine ≤ 2 x ULN
    - Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normality (ULN)
    - Total serum bilirubin ≤1.5 x ULN.
    E.4Principal exclusion criteria
    Previous surgical/endoscopic treatments for prostatic disease
    2. Food supplements or herbal products that in the opinion of the investigator may decrease PSA levels
    3. cM1 disease
    4. Any contraindication for PET or MR imaging
    5. History of seizure or condition that may pre-dispose to seizure (e.g., prior stroke within 1 year prior to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
    6. Medications known to lower the seizure threshold (Appendix 2)
    7. History of:
    - Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer currently in complete remission) within 5 years prior to randomization
    - Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant
    ventricular arrhythmias within 6 months prior to randomization
    - Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥100 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
    - Gastrointestinal disorder affecting absorption
    8. Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in proportions of patients with minimal residual disease (MRD: tumor volume ≤ 0.25 cm3 at final pathology) between the two arms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    [ Time Frame: After 12 weeks of neoadjuvant therapy + RP + PLND ]
    E.5.2Secondary end point(s)
    1. Difference in proportions of pathological downstage
    2. Complete pathological response rates
    3. Difference in proportions of patients with pN1 disease.
    4. Proteins expression in prostatic tumour TMA's (tissue microarrays)
    5. Transcriptome analysis by microarray expression platform
    6. Pathway profiling and Gene Set Enrichment Analyses
    7. Genomic subtyping by exome-sequencing
    8. PSA kinetics
    9. Testosterone kinetics
    10. PSA nadir </=0.3ng/ml after neoadjuvant treatment
    11. Peri-operative features
    12. Differences in proportions of surgical complications between arms
    13. Continence
    14. Quality of life
    15. Erection state
    16. Survival
    17. Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR per arm
    18. Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR between arms
    19. Standardized Uptake Value (SUV) on pelvic [68]Ga PSMA PET/MR and tumour volume
    20. Standardized Uptake Value (SUV) on prostate [68]Ga PSMA PET/MR and Immunohistochemistry
    21. Magnetic resonance (MR) and tumor volume (TV) per arm
    22. Magnetic resonance (MR) and tumor volume (TV) between arms
    23. PI-RADS between arms at MR
    24. PI-RADS score and Gleason score
    25. Down-staging at imaging
    26. Incidence of Treatment-Emergent Adverse Events

    E.5.2.1Timepoint(s) of evaluation of this end point
    1.After 12 weeks of neoadjuvant therapy (NAT)
    2.After 12 weeks of NAT
    3.After 12 weeks of NAT
    4.After 12 weeks of NAT
    5.At baseline and after 12 weeks of NAT
    6.At baseline and after 12 weeks of NAT
    7.At baseline and after 12 weeks of NAT
    8.Up to 40 months
    9.Up to 40 months
    10.After 12 weeks of NAT
    11.Up to (about) 5 hours
    12.Up to 6 weeks post surgery
    13.Up to 40 months
    14.Up to 40 months
    15.Up to 40 months
    16.Up to 36 months
    17.At baseline and after 12 weeks of NAT
    18.After 12 weeks of NAT
    19.After 12 weeks of NAT
    20.After 12 weeks of NAT
    21.At baseline and after12 weeks of NAT
    22.At baseline and after12 weeks of NAT
    23.After 12 weeks of NAT
    24.After 12 weeks of NAT
    25.At baseline and after 12 weeks of NAT
    26.From patient inclusion until surgery
    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 No
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    degarelix + placebo
    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 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
    End of trial: when the last patient will end the 3 years follow up.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 state102
    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)
    Standard of care
    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 Decision2017-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-07-22
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