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    Summary
    EudraCT Number:2014-001128-31
    Sponsor's Protocol Code Number:13-23
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-15
    Trial results View 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 ConcernedIreland - HPRA
    A.2EudraCT number2014-001128-31
    A.3Full title of the trial
    Phase II Single-arm Study evaluating Neo-adjuvant (pre-radical radiotherapy) Abiraterone acetate (plus prednisolone) and Gonadotropin-Releasing Hormone (GnRH) agonist in high risk localised prostate carcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II single-arm study evaluating abiraterone acetate (plus prednisolone) and Gonadotropin-Releasing Hormone (GnRH) agonist prior to receiving radical radiotherapy in high risk localised prostate carcinoma patients
    A.3.2Name or abbreviated title of the trial where available
    Phase II neo-adjuvant abiraterone prostate study
    A.4.1Sponsor's protocol code number13-23
    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 SponsorCancer Trials Ireland
    B.1.3.4CountryIreland
    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 Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCancer Trials Ireland
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, Old Finglas Road, Glasnevin
    B.5.3.2Town/ cityDublin
    B.5.3.3Post codeD11 KXN4
    B.5.3.4CountryIreland
    B.5.4Telephone number+353 16677211
    B.5.6E-mailregulatory@cancertrials.ie
    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 Zytiga
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameabiraterone acetate
    D.3.4Pharmaceutical form 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 INNabiraterone acetate
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeabiraterone acetate
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeSUB31647
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    High-risk prostate cancer
    E.1.1.1Medical condition in easily understood language
    Prostate cancer with a high risk of progressive disease
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10060862
    E.1.2Term Prostate cancer
    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
    Primary Objective:
    To evaluate the clinical tumour and biochemical response, and mean percentage reduction in prostate gland volume; achieved by 126 days of neo-adjuvant combined treatment by abiraterone acetate, prednisolone and GnRH agonist - in treatment naïve high-risk localised prostate carcinoma patients (prior to radical radiotherapy).
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1) To report the decrease in testosterone level
    2) To report the PSA kinetics and response on the studied treatment
    3) To evaluate the potential change in urinary symptoms
    4) To report the androgen deprivation-related symptoms and treatment-related toxicities
    5) To report the safety profile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study 1 title: CYP17 germline mutations:

    Objectives:
    - Isolate deoxyribonucleic acid (DNA) from blood samples collected from men receiving abiraterone acetate as part of the proposed study
    - To investigate an association between candidate polymorphisms in CYP17 and response to abiraterone acetate
    - To perform full sequencing of CYP17 and investigate an association between germline variation and response and toxicity.

    Sub-study 2 title: Biomarker discovery for predicting and monitoring response to therapy:

    Objectives:
    - Collect serum and plasma samples before, during and after treatment
    - Undertake proteomic discovery using label-free liquid chromatography tandem mass spectrometry (LC-MS/MS) technologies coupled with appropriate bioinformatics and biostatistics approaches to identify panels of proteins that would (1) predict response and (2) monitor responses and could be used to appropriately select patients for treatments with abiraterone acetate.

    E.3Principal inclusion criteria
    Each patient must meet all of the following inclusion criteria to be eligible for the study:

    1. Provision of written informed consent prior to any study-related procedures

    2. Male age ≥ 18 years of age

    3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (See Appendix B of the study protocol)

    4. Life expectancy ≥ 10 years, as per clinician’s decision

    Select Ireland - Scroll to ‘expectation of life at age x’ using the most recent indicator for Males)
    5. Pathological proven prostate carcinoma at intermediate to high risk of recurrence as defined by RTOG:
    • Gleason ≥8; or clinical stage ≥T3a; or PSA(#) ≥20 ng/ml(equivalent to AJCC 7th edition 2010 (Edge et al., 2010) / UICC group IIB and III)

    • Or 2 or more of the following factors:
    Gleason = 7;
    PSA >10 ng/ml but ≤20 ng/ml,
    T2b-2c (equivalent to AJCC 7th edition 2010 (Edge et al. 2010) / UICC group II)

    • And planned for radical radiotherapy (External Beam radiation therapy/ Brachytherapy / combination of both) and with an indication for neo-adjuvant hormonal therapy
    [Note: (#): Study entry PSA must not be obtained during the following time frames:
    (1) 10-day period following prostate biopsy;
    (2) following initiation of ADT;
    (3) within 30 days after discontinuation of finasteride;
    or (4) within 90 days after discontinuation of dutasteride]

    6. Clinically negative lymph nodes (N0) as established by imaging (pelvic CT / MRI), nodal sampling, or dissection within 90 days prior to registration, except patients with lymph nodes equivocal or questionable by imaging are eligible without biopsy if the nodes are ≤1.5 cm; any node larger than this on imaging will require negative biopsy for eligibility.

    7. No evidence of bone metastases (M0) on bone scan within 90 days prior to registration. Equivocal bone scan findings are allowed if plain film x-rays are negative for metastasis.

    8. Clinical laboratory values during screening:
    • Haemoglobin ≥ 10.0 g/dl
    • Absolute neutrophil count (ANC) ≥ 1.8 × 109/L
    • Platelets ≥ 100 × 109/L
    [Note: Study patients need to meet the above 3 criteria independent of growth factors and transfusions]
    • Total bilirubin ≤ 1.5× upper limit of normal (ULN)
    • Alanine (ALT) and aspartate (AST) aminotransferase ≤ 2.5 × ULN
    • Alkaline Phosphatase (ALP) ≤ 6 × ULN
    • Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (Calculated GFR using Cockcroft and Gault Formula) (see Appendix C of the study protocol)
    • Serum potassium ≥3.5 mM
    • Serum albumin ≥3.0 g/dL
    • Clinically normal prothrombin (PT) or international normalised ratio (INR) per Investigator assessment

    9. Systolic blood pressure <160 mmHg and diastolic blood pressure <95 mmHg
    [Note: medically controlled hypertension is permitted]

    10. Prostate gland size measurable by TRUS and at least ≥30 cm3 at baseline (in accordance with Ferring CS 30 study - NCT00833248)

    11. Patient is willing to use barrier-method contraception, e.g. a condom, along with another effective contraceptive method if engaged in sexual activity with a pregnant woman or a woman of child-bearing potential (until 1 week after completing treatment)
    E.4Principal exclusion criteria
    Each patient must meet none of the following exclusion criteria to be eligible for the study:

    1. Prior treatment for prostate carcinoma, including prostatectomy; high-intensity focused ultrasound or cryotherapy; hormonal manipulation (any modalities) including LHRH agonist, anti-androgen, or bilateral orchidectomy; prior or concomitant chemotherapy for prostate cancer; prior radiotherapy including brachytherapy to the region of study cancer; radical local treatment [Exception: TURP / TRUS is allowed]

    2. Use of urethral catheter (in accordance with Ferring CS 30 study - NCT00833248)

    3. History of cardiovascular disease; Uncontrolled hypertension [hypertension controlled by anti-hypertensive therapy is permitted], clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III or IV heart failure (See Appendix E of the study protocol), or Class II to IV heart failure of cardiac ejection fraction measurement of <50% [cardiac ejection fraction measured by MUGA or ECHO - if indicated, at Investigator’s discretion]

    4. Active or symptomatic viral hepatitis, chronic liver disease or severe hepatic impairment

    5. Major thoracic or abdominal surgery or significant traumatic injury within 4 weeks prior to registration, or planned surgery during study participation / within 4 weeks from end of treatment [Note: patients with planned surgical procedure to be conducted under local anaesthesia are not excluded from the study]

    6. Gastrointestinal disorder interfering with study drug absorption

    7. Active or uncontrolled disease that may require oral corticosteroid therapy

    8. Positive serology for hepatitis B surface antigen or hepatitis C antibody

    9. Known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisolone, GnRH agonists or their excipients

    10. Contraindications to the use of prednisolone or GnRH agonists per local prescribing information

    11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

    12. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments

    13. The patient has or had other co-existing malignancies within the past 5 years, other than resected non-melanoma skin cancer

    14. Treatment with non-approved or investigational drug within 30 days before the first planned dose of study drug

    15. Treatment with any prohibited medication (as outlined per protocol section 7.4.1) which cannot be discontinued.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints:

    i. Mean reduction in prostatic volume as compared to baseline, by repeated prostate volume measurement by TRUS (prior to treatment and on day 126) (+ / - 3 days)
    ii. Median change in PSA level after 126 days of study treatment as compared to baseline (prior to treatment, and on day 126) (+/- 3 days)
    iii. Percentage of patients achieving a complete clinical and biochemical response as defined by a normalisation of digital rectal exam (DRE) and an achieved PSA < 0.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    TRUS: 126 days compared to baseline values
    PSA: 126 days compared to baseline values
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:

    1) Decrease in testosterone level will be evaluated by serial measurements prior to treatment and on days 15, 43, 71, 99, and 126 (+/- 3 days).
    2) The PSA kinetics and response on the studied treatment will be evaluated by serial PSA measurement prior to treatment and on days 15, 43, 71, 99, and 126 (+/- 3 days).
    3) The studied treatment impact on urinary symptoms will be evaluated by serial International Prostate Symptom Score (IPSS) prior to treatment and on days 15, 43, 71, 99, and 126 (See Appendix F of the study protocol) (+/- 3 days).

    Secondary Toxicity/ Safety Endpoints:

    1) The potential toxicity of the studied treatment will be evaluated by:
    i. NCI CTCAE Version 4.0 Grading system for Androgen deprivation-related symptoms (See Appendix D of the study protocol)
    ii. Serial IIEF scores for erectile dysfunction prior to treatment and on days 15, 43, 71, 99, and 126 (See Appendix G of the study protocol) (+/- 3 days)

    2) The safety of the studied treatment will be evaluated by:
    i. Frequency and grade of AEs (Grade ≥ 4 toxicity event)
    ii. Clinically relevant changes in laboratory values
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 15, 43, 71, 99, and 126 compared to baseline values
    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 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 concerned3
    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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 27
    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 state36
    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)
    After the study ends: follow up standard radiotherapy/brachytherapy treatment plus hormones for the patients will be as per physician’s discretion, and patients will be followed as per institutional practice.
    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 Decision2014-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-19
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