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    Summary
    EudraCT Number:2017-000099-27
    Sponsor's Protocol Code Number:HEAT01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-11
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-000099-27
    A.3Full title of the trial
    Toxicity of first-line abiraterone versus enzalutamide in men with metastatic castration-resistant prostate cancer: A randomized clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The HEAT-study
    (The Herlev Enzalutamide versus Abiraterone Toxicity-study)
    A.3.2Name or abbreviated title of the trial where available
    HEAT
    A.4.1Sponsor's protocol code numberHEAT01
    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 SponsorThe Department of Urology
    B.1.3.4CountryDenmark
    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 supportThe Department of Urology
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Department of Endocrinology
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Department of Pathology
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Department of Urology
    B.5.2Functional name of contact pointThe Department of Urology
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code​2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538689927
    B.5.6E-mailklara.kvorning.ternov@regionh.dk
    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 Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameXtandi
    D.3.4Pharmaceutical form Capsule, soft
    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 INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.4EV Substance CodeSUB77412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 mg
    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 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 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.3.4Pharmaceutical 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
    D.3.9.1CAS number 154229-19-3
    D.3.9.4EV Substance CodeSUB07361MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number 250
    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
    Metastisc castration resistant prostate cancer
    E.1.1.1Medical condition in easily understood language
    progression of the prostate cancer despite castration treatment
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory 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
    The main objective of this project is to investigate if there is a group-difference in treatment related adverse effects between abiraterone and enzalutamide in regards to:

    • Fatigue
    • Metabolic profile
    • Health related quality of life (HQoL)

    The aim of preforming the above is to generate knowledge in order to enable a more individualized treatment of patients with mCRPC, based on the therapies profile of adverse effects and the patients’ individual needs.
    E.2.2Secondary objectives of the trial
    "Not applicable"
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarkers predictive and prognostic value

    Date: The substudy will be made 1 and 3 years (approx. 1 June 2020 and 1 June 2023) after the last patients visit.

    Objective:The main objective is to investigate the predictive value of ARV-7(androgen receptor variant 7) in men undergoing 1. line novel second generation hormonal therapy for mCRPC. Furthermore, the prognostic and predictive value of volume of bone metastases from bone scan will be investigated. Other prognostic biomarkers in cellfree DNA/RNA will also be investigated.
    E.3Principal inclusion criteria
    • Eligible for first line treatment with either abiraterone or enzalutamide as per standard of care guidelines
    • Age 18-90 years
    • Willing, capable and legally competent individuals
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (see appendix)
    • Histologically confirmed adenocarcinoma of the prostate
    • Prior surgical orchiectomy or if on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist then testosterone < 1.7 nmol/L at screening visit (patients must maintain LHRH agonist/antagonist therapy for duration of study treatment if not surgically castrated)
    • Evidence of metastatic disease on bone scan or CT scan
    • Evidence of biochemical or imaging progression in the setting of surgical or medical castration. Progressive disease for study entry is defined by one of the following criteria based on criteria of prostate cancer working group 3 (PCWG3):
    o Biochemical progression: Obtain sequence of rising PSA values at a minimum of 1-week intervals, resulting in increases over the nadir, with PSA > 1 ng/mL
    o Radiological progression:
     The appearance of two or more new bone lesions on bone scan
     Enlargement of a soft tissue lesion using the modified RECIST 1.1.
    • > NYHA2, in case of cardiac comorbidity
    • Adequate organ function defined as:
    o Creatinine < 1,5 x the upper limit of normal (ULN)
    o Total bilirubin < 1,5 x ULN
    o Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2,5 x ULN
    o White blood cell count ≥3,0 109/L
    o Platelet count ≥ 100 109/L
    E.4Principal exclusion criteria
    • Inability to understand and/or stick to the written information
    • Previous treatment with docetaxel, with the exception of previous treatment with early docetaxel (≤ 6 series) ≥6 months before inclusion.
    • Diagnosed with diabetes mellitus and/or HbA1C > 48 mmol/mol. 

    • Hypersensitivity towards components in abiraterone or enzalutamide
    • Ongoing treatment with high doses of glucocorticoids
    • Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
    • Prior therapy with CYP17 inhibitors (including abiraterone acetate, TAK-700, TOK-001 and ketoconazole), enzalutamide or other experimental anti-androgens (e.g. ARN-509, TOK-001)
    • Life expectancy < 6 months
    • Active concurrent malignancy
    • Treatment with Radium-223
    • Known brain metastases
    • Liver or lung metastases on CT-scanning.
    • History of seizure or seizure disorder, or history of cerebrovascular stroke within 6 months of study entry.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint

    Between-group differences in changed level of fatigue assessed with the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial is completed with the last patients’ last visit. Approx. from 1 February 2017 to 1 June 2019, with the enrollment and 3 months’ follow-up in the intervening period.
    E.5.2Secondary end point(s)
    • Between-group differences in changed level of fasting plasma-glucose, plasma-insulin and HOMA-index
    • Between-group differences in changed level of blood-hemoglobin A1c (HbA1c)
    • Between-group differences in changed levels of cardiac biomarkers (NT-proANP, MR-proADM, GAL-3, hsTNT, GDF-15, PIGF, sFlt-1, NT-proBNP, MR-proANP, Retinol binding protein 4, α-defensin, Relaxin and OPG)
    • Between-group differences in changed levels of Adipose biomarkers (FFA, TNF- α, IL-6, MCP-1, MAC-1, COLL- A1, FGF-21, total and high molecular adiponectin,)
    • Between-group differences in changed systolic and diastolic blood pressure measured after 20 min. of relaxation
    • Between-group differences in changed levels of serum lipids (Total cholesterol, Triglycerides, Low density lipoproteins (LDL), High density lipoproteins (HDL) and very low density lipoproteins (VLDL))
    • Between-group differences in changed levels of inflammatory biomarkers (CRP and Leptin)
    • Between-group differences in changed levels of hormones (FSH, LH, Total Testosterone; Free Testosterone, Dehydroepiandrosterone Sulfate (DHEAS), Sex Hormone Binding Globulin (SHBG),17-Hydroxyprogesterone, Androstenedione)
    • Between-group differences in changed weight and Body Mass Index (BMI)
    • Between-group differences in changed lean body mass, total fat mass, visceral and subcutaneous fat volume (VAT and SAT) measured by a Dual-Energy X-ray Absorptiometry scanner (DXA-scanner)
    • Between-group differences in changed level of Health-related Quality of Life (HQoL) assessed from the questionnaire Functional Assessment of Cancer Therapy - for patients with Prostate cancer (FACT-P)

    The subgroup analysis
    • Between-group differences in changed insulin sensitivity within the first 60 patients, measured by Oral Glucose Tolerance Test (OGTT) with evaluation of the Matsuda Index and the homeostatic model assessment (HOMA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The trial is completed with the last patients’ last visit. Approx. from 1 February 2017 to 1 June 2019, with the enrollment and 3 months’ follow-up in the intervening period.
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    head to head trial: enzalutamide versus abiraterone
    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 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
    The trial is completed with the last patients’ last visit. Approx. from 1 February 2017 to 1 June 2019, with the enrollment and 3 months’ follow-up in the intervening period.
    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 months3
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 135
    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 state170
    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)
    No trial treatment afterwards, patients will receive 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 Decision2017-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-06
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