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    Summary
    EudraCT Number:2019-003177-26
    Sponsor's Protocol Code Number:RT2019-13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-11-26
    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 number2019-003177-26
    A.3Full title of the trial
    Androgen Deprivation therapy for Oligo-recurrent Prostate cancer in addition to radioTherapy
    Androgeendeprivatietherapie voor Oligo-recidiverende prostaatkanker in aanvulling op radiotherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of targeted radiotherapy with and without short-term hormonal treatment (6 months)
    Vergelijken van gerichte radiotherapie met en zonder kortdurende hormonale behandeling (6 maanden)
    A.3.2Name or abbreviated title of the trial where available
    ADOPT
    ADOPT
    A.4.1Sponsor's protocol code numberRT2019-13
    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 SponsorUMCG
    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 supportUMCG
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMCG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.6E-mails.al-uwini@umcg.nl
    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 Eligard, Leuproline acetaat 1x 45 mg sc
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma 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 nameEligard
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEUPRORELIN ACETATE
    D.3.9.1CAS number 74381-53-6
    D.3.9.4EV Substance CodeSUB02900MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    Patients with biochemical recurrence after primary treatment of prostate cancer presenting with ≤4 metastases
    Patiënten met biochemisch recidief na primaire behandeling van prostaatkanker met ≤4 metastasen
    E.1.1.1Medical condition in easily understood language
    Metastatic prostate cancer
    Uitgezaaide prostaat kanker
    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
    The overall aim of this project is to test the hypothesis that the addition of ADT to metastasis-directed radiotherapy (MDRT) in well-selected PCa patients with oligo-metastatic disease prolongs the metastases progression-free survival (MPFS) compared to MDRT alone
    Het algemene doel van dit project is de hypothese te testen dat de toevoeging van ADT aan metastase-gerichte radiotherapie (MDRT) bij goed geselecteerde PCa-patiënten met oligo-metastatische ziekte de metastasen-progressievrije overleving (MPFS) verlengt in vergelijking met alleen MDRT
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically proven initial diagnosis of adenocarcinoma of the Prostate.
    2. Biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the EAU guidelines 2018. BCR after surgery: PSA > 0.1ng/ml. BCR after radiotherapy: PSA nadir +2 ng/ml (after exclusion of possible bounce effect).
    3. Maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases.
    a. Nodal relapse (N1) in the pelvis on PSMA-PET scan with a maximum of 4 positive lymph nodes. The upper limit of the pelvis is defined as the aortic bifurcation.
    b. Nodal relapse (M1) on PSMA-PET scan above the aortic bifurcation with a maximum of 3 positive lymph nodes.
    c. Bone relapse on PSMA-PET scan with a maximum of 3 lesions.
    4. Age > 18 years.
    5. PSMA-PET/CT scan or PSMA-PET/MRI within 60 days prior to randomization.
    6. PSA < 10 ng/ml.
    7. In case of chronic use of finasteride the PSA value should be < 5 ng/ml
    8. WHO performance state 0-2.
    9. Signed informed consent prior to registration/randomization.
    1. Histologisch bewezen initiële diagnose van adenocarcinoom van de prostaat.
    2. Biochemische herhaling van prostaatkanker na primaire lokale prostaatbehandeling (radicale prostatectomie, primaire radiotherapie of radicale prostatectomie +/- adjuvante berging radiotherapie) volgens de EAU-richtlijnen 2018. BCR na chirurgie: PSA> 0,1 ng / ml. BCR na radiotherapie: PSA nadir +2 ng / ml (na uitsluiting van mogelijk bounce-effect).
    3. Maximaal 4 laesies (bot + lymfeklieren) in totaal, zonder bewijs van viscerale metastasen.
    a. Nodal recidief (N1) in het bekken op PSMA-PET scan met maximaal 4 positieve lymfeklieren. De bovengrens van het bekken wordt gedefinieerd als de aortabifurcatie.
    b. Nodale recidief (M1) op PSMA-PET scan boven de aortabifurcatie met maximaal 3 positieve lymfeklieren.
    c. Terugval van het bot op PSMA-PET scan met maximaal 3 laesies.
    4. Leeftijd> 18 jaar.
    5. PSMA-PET/CT scan of PSMA-PET/MRI binnen 60 dagen voorafgaand aan randomisatie.
    6. PSA <10 ng / ml.
    7. In geval van chronisch gebruik van finasteride moet de PSA-waarde <5 ng / ml zijn
    8. WHO-prestatiestatus 0-2.
    9. Ondertekende geïnformeerde toestemming voorafgaand aan registratie / randomisatie.
    E.4Principal exclusion criteria
    1. Visceral metastases.
    2. PSA ≥ 10 ng/ml.
    3. PSA-doubling time < 3 months.
    4. ADT or chemotherapy for recurrent PCa.
    5. Testosterone < 1.7 nmol/l
    6. Painful metastases needed pain medication
    7. Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.
    8. Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
    Tekst


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    Nederlands

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    1. Visceral metastases.
    2. PSA ≥ 10 ng/ml.
    3. PSA-doubling time < 3 months.
    4. ADT or chemotherapy for recurrent PCa.
    5. Testosterone < 1.7 nmol/l
    6. Painful metastases needed pain medication
    7. Previous or concurrent invasive active cancers other than superficial non-melanoma skin cancers.
    8. Inability to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.
























    422/5000


























    1. Viscerale metastasen.
    2. PSA ≥ 10 ng / ml.
    3. PSA-verdubbelingstijd <3 maanden.
    4. ADT of chemotherapie voor terugkerende PCa.
    5. Testosteron <1,7 nmol / l
    6. Pijnlijke metastasen hadden pijnmedicatie nodig
    7. Eerdere of gelijktijdige invasieve actieve kankers anders dan oppervlakkige niet-melanoom huidkanker.
    8. Onvermogen om de informatie over proefgerelateerde onderwerpen te begrijpen, geïnformeerde toestemming te geven of QoL-vragenlijsten in te vullen.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the 2-year metastases progression free survival
    Het primaire eindpunt is de 2-jarige metastasen progressievrije overleving
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    -
    E.5.2Secondary end point(s)
    Secondary endpoints are acute and late toxicity, quality of life (QoL), biochemical recurrence free survival and overall survival

    - 3 years PSA progression
    - Start of 2nd line treatment
    - Start 2nd MDRT treatment for new (progressive) oligo-metastases
    - Acute and late toxicity (late toxicity up to 3 years)
    - Clinical progression-free survival
    - Quality of life
    - Relapse pattern
    - Time to start of palliative ADT
    - Time to castration-resistance
    - Disease-specific and overall survival
    - Sensitivity of the imaging modality (PSMA-PET/CT or PSMA-PET/MRI) for patients receiving MDRT
    Secundaire eindpunten zijn acute en late toxiciteit, kwaliteit van leven (QoL), biochemische recidiefvrije overleving en totale overleving
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    -
    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 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
    alleen radiotherapie
    only radiotherapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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
    ???? / 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 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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state280
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 280
    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
    geen
    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 Decision2019-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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