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    Summary
    EudraCT Number:2020-003012-27
    Sponsor's Protocol Code Number:18062020
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-003012-27
    A.3Full title of the trial
    Impact of peri-operative tEstosterone levels oN Functional and oncological Outcomes following RadiCal prostatEctomy
    De invloed van peri-operatieve testosteronniveau op functionele en
    oncologische uitkomsten na Radicale Prostatectomie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of testosterone on sexual functioning, urinary continence and oncological outcome following radical prostatectomy
    De invloed van testosterone op erecties, urinecontinentie en oncologische uitkomsten na radicale prostatectomy
    A.3.2Name or abbreviated title of the trial where available
    ENFORCE
    ENFORCE
    A.4.1Sponsor's protocol code number18062020
    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 SponsorCanisius Wilhelmina Ziekenhuis
    B.1.3.4CountryNetherlands
    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 supportTo be determined
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCanisius Wilhelmina Ziekenhuis
    B.5.2Functional name of contact pointTrialcoordinator
    B.5.3 Address:
    B.5.3.1Street AddressWeg door Jonkerbos 100
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6532 SZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243658832
    B.5.5Fax number+31243658097
    B.5.6E-maild.baas@cwz.nl
    D. IMP Identification
    D.IMP: 1
    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 Nebido
    D.2.1.1.2Name of the Marketing Authorisation holderBayer BV
    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 nameTestosterone undecanoate
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTESTOSTERONE UNDECANOATE
    D.3.9.3Other descriptive nameTESTOSTERONE UNDECANOATE
    D.3.9.4EV Substance CodeSUB04744MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Late-onset hypogonadism
    Hypogonadisme
    E.1.1.1Medical condition in easily understood language
    Low testosterone
    Verlaagd testosteron
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP, leads to better outcomes in the domain of sexual functioning 12 months after Radical Prostatectomy (RP) compared to testosterone deficient men who receive placebo therapy.
    Het effect van testosteronniveau en -suppletie op functionele en oncologische uitkomsten na RP evalueren.
    E.2.2Secondary objectives of the trial
    Evaluate if TRT in (a)symptomatic testosterone deficient men with prostate cancer undergoing RP leads to better

    outcomes in the domain of sexual functioning 3 months after Radicale Prostatectomy (RP).
    outcomes in the domain of sexual functioning 24 months after RP.
    outcomes in the domain of urinary continence 12 months after RP.
    outcomes in the domain of urinary continence 24 months after RP.
    outcomes in the domain of hormonal functioning 12 months after RP.
    outcomes in the domain of hormonal functioning 24 months after RP.
    to both a reduction of and longer interval to BCR following RP, at 1, 2 and 5 years after RP.

    Exploratory objective: gain insight on the effect of RP on serum testosterone levels in both patients with normal pre-operative
    Evalueren of testosterontherapie bij (a)symptomatische mannen met verlaagd testosteron leidt tot verbeterd:
    Seksueel functioneren 3 maanden na radicale prostatectomie (RP)
    Seksueel functioneren 24 maanden na radicale prostatectomie (RP)
    Urine continentie 12 maanden na RP (EPIC-26 continentie domein scores)
    Urine continentie 24 maanden na RP (EPIC-26 continentie domein scores)
    Hormonaal functioneren 12 maanden na RP (EPIC-26 hormonaal domein score)
    Hormonaal functioneren 24 maanden na RP (EPIC-26 hormonaal domein score)
    Het optreden van een biochemisch recidief (gedefinieerd als tweemaal PSA > 0.2) op 1, 2 en 5 jaar na RP.

    Exploratief:
    Effect van een RP op het beloop van testosteron bij mannen met een normaal peroperatief testosteron.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Prescreening eligibility criteria
    1. Signed informed consent form 1 (IC)
    2. Age > 18 years
    3. Histologically confirmed prostate cancer
    4. Scheduled for radical prostatectomy (RP) as primary treatment with at least one-side nervesparing
    5. Non-metastatic disease (cN0M0)
    6. Willing to provide two or three (depending on outcome) blood samples to determine testosterone level
    7. Willing to undergo testosterontherapy/placebo by intramuscular injection
    8. a mimimal sexual functioning of 40 points in the EPIC-26 sexual functioning domain score.

    Inclusioncriteria:
    8. Signed informed consent form 2 (IC)
    9. Undetectable PSA level at 4-week follow-up
    10. pT2-pT3a on specimen after RP
    11. ISUP 1-3 independent of surgical margin status or ISUP 4-5 with negative surgical margins.
    12. No metastatic lymphnodes in case a pelvic lymphnode dissection has been performed.
    13. No general contra-indications for testosterone therapy
    Prescreening criteria:
    1. getekend informed consent formulier 1 (IC)
    2. Leeftijd > 18 en
    3. Histologisch bewezen prostaatkanker
    4. Gepland voor radicale prostatectomie als primaire lokale behandeling voor prostaatcarcinoom met tenminste een-zijde zenuwsparend.
    5. niet-gemetastaseerde ziekte (cN0M0)
    6. bereid om twee of drie keer bloed af te laten nemen om het testosteronniveau te bepalen
    7. bereid om testosterontherapie/placebo te ondergaan middels intramusculaire injectie.
    8. Een minimale score van 40 punten voor het domein seksueel functioneren van de EPIC-26 vragenlijst.

    Inclusiecriteria (indien prescreening succesvol is doorlopen)
    8. getekend informed consent formulier 2
    9. onmeetbaar PSA 4 weken na de radicale prostatectomie
    10. pT2-pT3a als pathologisch T-stadium na radicale prostatectomie
    11. ISUP1-3 ongeacht de snijvlak-status of ISUP 4-5 met negatieve snijvlakken.
    12. Geen positieve lymfeklieren in het geval een klierdissectie is verricht.
    13. Geen algemene contra-indicaties voor het ontvangen van testosterontherapie.
    E.4Principal exclusion criteria
    Prescreening exclusion criteria:
    1. Any previous treatment for prostate cancer, for example but not limited to: anti-hormonal therapy, radiotherapy, brachytherapy (active surveillance is allowed)
    2. Previous use of testosterontherapy for any reason
    3. History of male breast cancer
    4. History of liver tumor
    5. Uncontrolled hypertension
    6. Allergy for components in the testosterone therapy agent or placebo
    7. Use of vitamin-K antagonists (acenocoumarol or fenprocoumon)
    8. metastases (cN1/M1)
    Prescreening exclusiecriteria:
    1. eerdere behandeling voor prostaatkanker zoals anti-hormonale therapie, radiotherapie, brachytherapie (active surveillance is toegestaan).
    2. eerder gebruik van testosterontherapie
    3. borstkanker in de voorgeschiedenis
    4. levertumor in de voorgeschiedenis
    5. onbehandelde hypertensie
    6. allergie voor componenten in Nebido of placebo.
    7. het gebruik van vitamine-K antagonisten (acenocoumarol of fenprocoumon)
    8. Metastasen (cN1/M1)
    E.5 End points
    E.5.1Primary end point(s)
    The main endpoint for this study is the total sexual domain score coming from the EPIC-26 questionnaire, 12 months after radical prostatectomy. A change of 12 points in this domain is considered clinically relevant.
    Seksueel functioneren 12 maanden na RP, bepaald middels PROMs (EPIC-26 seksueel functioneren domein score [0-100]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after radical prostatectomy
    12 maanden na radicale prostatectomie
    E.5.2Secondary end point(s)
    1. EPIC-26 sexual functioning domain score [0-100] at 3 months after RP. A difference of 12 points or more is considered clinically relevant.
    2. EPIC-26 sexual functioning domain score [0-100] at 24 months after RP. A difference of 12 points or more is considered clinically relevant.
    3. EPIC-26 urinary incontinence domain score [0-100] at 12 months after RP. A difference of 9 points or more is considered clinically relevant.
    4. EPIC-26 urinary incontinence domain score [0-100] at 24 months after RP. A difference of 9 points or more is considered clinically relevant.
    5. EPIC-26 hormonal functioning domain score [0-100] at 12 months after RP. A difference of 6 points or more is considered clinically relevant.
    6. EPIC-26 hormonal functioning domain score [0-100] at 24 months after RP. A difference of 6 points or more is considered clinically relevant.
    7. Occurrence of biochemical recurrence (two times detectable PSA > 0.2 ng/ml)
    8. In case of biochemical recurrence, time to recurrence in months.
    Secundair:
    - Continentie 12 maanden na radicale prostatectomie (EPIC-26 continentie domein scores)
    - Hormonaal functioneren 12 maanden na radicale prostatectomie (EPIC-26 hormonaal domein score)
    - Kwaliteit van leven 12 maanden na radicale prostatectomie (EQ5D5L score)
    - Aantal biochemisch recidieven (gedefinieerd als tweemaal PSA > 0.2)
    - Gemiddelde tijd tot het ontwikkelen van een Biochemisch recidief
    Exploratief:
    - Effect van een v op het beloop van testosteron bij mannen met een normaal peroperatief testosteron.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months, 12 months, 24 months and 5 years after radical prostatectomy
    3 maanden, 12 maanden, 24 maanden en 5 jaar na radicale prostatectomie
    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 No
    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) 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned6
    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
    5 years after randomization of the last subject
    5 jaar na randomisatie van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 350
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state750
    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 Decision2020-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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