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    Summary
    EudraCT Number:2013-002553-29
    Sponsor's Protocol Code Number:kk-2013
    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:2013-07-15
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-002553-29
    A.3Full title of the trial
    Metabolic changes due to iatrogenic hypogonadism in patients with prostate cancer: orchiectomy vs. triptorelin
    Metaboliske ændringer hos patienter med prostatakræft som følge af iatrogen hypogonadisme: orkiektomi vs. triptorelin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Surgical versus medical castration therapy: Are the effects on risk factors for cardiovascular disease and bone density different.
    Kirurgisk versus medicinsk kastrationsbehandling: Er der forskel i påvirkning af risikofaktorer for hjertekarsygdom og knogleskørhed?
    A.4.1Sponsor's protocol code numberkk-2013
    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 SponsorJens Sønksen
    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 supportDepartment of Urology, Herlev Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Endocrinology, Herlev Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Urology, Herlev Hospital
    B.5.2Functional name of contact pointDepartment of Urology, Herlev Hospi
    B.5.3 Address:
    B.5.3.1Street AddressHerlev Ringvej 75
    B.5.3.2Town/ cityHerlev
    B.5.3.3Post code2730
    B.5.3.4CountryDenmark
    B.5.4Telephone number004538681505
    B.5.6E-mailpeter.busch.oestergren@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 Pamorelin
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN AB
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Men with prostate cancer where lifelong castration is indicated
    Mænd med prostatacancer, hvor livslang kastrationsbehandling er indiceret.
    E.1.1.1Medical condition in easily understood language
    Men with prostate cancer where lifelong castration is indicated
    Mænd med prostatacancer, hvor livslang kastrationsbehandling er indiceret.
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10067329
    E.1.2Term Chemical male castration
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10049629
    E.1.2Term Male operative castration
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10052066
    E.1.2Term Metabolic syndrome
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is to investigate if the modality of Androgen deprivation therapy is of importance when looking at body composition, glucose- and lipid metabolism and bone density.
    Projektets formål er at undersøge om der er forskel på kirurgisk og medicinsk kastration, med en GnRH agonist, hos patienter med prostatacancer i forhold til:
    - virkning på kropssammensætning
    - glukose- og lipidmetabolismen
    - knogletæthed
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. diagnosed prostate cancer, where life long ADT is indicated.
    2. Age 18 - 90 years
    3. ECOG performance status 0-2
    -Prostatakræftpatienter, hvor der er fundet indikation for livslang kastrationsbehandling.
    -Alder 18 – 90 år
    -ECOG performance status 0-2
    E.4Principal exclusion criteria
    1. Previous androgen deprivation therapy.
    2. Anti-androgen treatment befor start of ADT, antiflare treatment after randomisation is accepted.
    3. Hemophelia or other condition that increases the risk of complications for orchiectomy unreasonably.
    4. Prior treatment for osteoporosis.
    5. Known diabetes and/or HbA1C > 6,5
    -Deltageren har tidligere fået medicinsk kastrationsbehandling i form af en GnRH agonist eller antagonist.
    -Anti-androgen behandling inden påbegyndelse af kastrationsbehandlingen, antiflare behandling efter randomisering er dog undtaget.
    -Blødersygdom eller anden tilstand der øger komplikationsriskion for operation uforholdsvis meget.
    -Tidligere behandlet for knogleskørhed udover kalk og D-vitamin.
    -Kendt diabetes og/eller HbA1C > 6,5.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change in fasting blodglucose
    2. percent change in abdominal fat.
    -Ændring i faste blodsukker
    -Den procentvise ændring i abdominal fedt
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 12, 24 and 48 weeks.
    2. 24 and 48 weeks
    1. 12, 24 og 48 uger
    2. 24 og 48 uger.
    E.5.2Secondary end point(s)
    1. change in BMD
    2. change in bonemarkers
    3. change in se-lipids
    4. change in insulin sensitivity
    5. change in inflamation biomarkers
    6. change in NT-proBNP
    7. change in bloodpressure and BMI.
    8. change in QoL inkl. EHS (erection hardness scale)
    -Ændring i Bone Mineral Density (BMD)
    -Ændring i knoglemarkører
    -Ændring i Se-lipider
    -Ændring i insulinfølsomhed målt ved OGGT med bestemmelse af Matsuda index.
    -Ændring i inflammationsmarkører (CRP og Adiponectin)
    -Ændring i NT-proBNP
    -Ændring i BT og BMI
    -Ændring i QoL målt ud fra evalueringsskemaerne EORTC QLQ-C30 og EORTC PR-25.
    -Ændring i rejsningsfunktion ud fra Erection Hardness Score (EHS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 24 and 48 weeks.
    2.-7.: 12, 24 and 48 weeks.
    1. 24 og 48 uger
    2. - 7.: 12, 24 og 48 uger.
    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 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
    orkiektomi
    orchiectomy
    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
    LVLS
    LVLS
    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 months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state58
    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)
    None
    Ingen
    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 Decision2013-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-12
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