Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,477
Countries
15
Sites
72
Metastatic castration resistant prostate cancer
1. To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1, as assessed by BICR in participants with mCRPC.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 24 Mar 2026 → ongoing
- Decision date (initial)
- 2024-03-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Orion Corporation · Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2023-504957-11-00
- WHO UTN
- U1111-1288-5002
- ClinicalTrials.gov
- NCT06136650
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacogenetic, Efficacy, Pharmacodynamic, Therapy, Pharmacokinetic, Pharmacogenomic
1. To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1, as assessed by BICR in participants with mCRPC.
Secondary objectives 9
- To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to overall survival in participants with mCRPC.
- To evaluate the TFST of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
- To evaluate the OR and DOR per PCWG Modified RECIST 1.1 as assessed by BICR of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
- To evaluate TTPP of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
- To evaluate MK-5684 and abiraterone acetate or enzalutamide with respect to health-related quality of life (HRQoL) using the FACT-P questionnaire.
- To evaluate the time to PSA progression of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
- To evaluate the PSA response rate of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
- To evaluate the time to first SSRE of participants treated with MK-5684 compared with participants treated with alternative abiraterone acetate or enzalutamide.
- To evaluate the safety and tolerability of MK-5684.
Conditions and MedDRA coding
Metastatic castration resistant prostate cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10076506 | Castration-resistant prostate cancer | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
- Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)
- Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer [mHSPC] or non-metastatic hormone-sensitive prostate cancer [nmHSPC]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer [mCRPC[ or non-metastatic castration-resistant prostate cancer [nmCRPC]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
- Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- Has ongoing androgen deprivation therapy (ADT) with serum testosterone <50 ng/dL (<1.7 nM)
- Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
- Has adequate organ function
- Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
- Participants who are hepatitis B surface antigen (HbsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion criteria 28
- Has presence of gastrointestinal condition
- Is unable to swallow capsules/tablets
- Has history of pituitary dysfunction
- Has poorly controlled diabetes mellitus
- Has clinically significant abnormal serum potassium or sodium level.
- Has any of the following at Screening Visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
- Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
- Has history or family history of long QTc syndrome
- Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
- Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
- Has not adequately recovered from major surgery or have ongoing surgical complications
- Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
- Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
- Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
- Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
- Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat (MK-5684)
- Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
- Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
- Active infection requiring systemic therapy
- Has concurrent active Hepatitis B virus and Hepatitis C virus infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Radiographic Progression-free Survival (rPFS)
Secondary endpoints 13
- Overall Survival (OS)
- Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Time to Pain Progression (TTPP)
- Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
- Time to Deterioration (TTD) in FACT-G Total Score
- Overall Improvement in FACT-G Total Score
- Time to Prostate-specific Antigen (PSA) progression
- PSA Response Rate
- Time to first symptomatic skeletal-related event (TSSRE)
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10441547 · Product
- Active substance
- Opevesostat Tosilate
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10675 mg milligram(s)
- Max treatment duration
- 35 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 6
SUB31647 · Substance
- Active substance
- Abiraterone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1067500 mg milligram(s)
- Max treatment duration
- 35 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB31647 · Substance
- Active substance
- Abiraterone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1067500 mg milligram(s)
- Max treatment duration
- 35 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB77412 · Substance
- Active substance
- Enzalutamide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 170800 mg milligram(s)
- Max treatment duration
- 35 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB04024MIG · Substance
- Active substance
- Prednisone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12810 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12810 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 12810 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 9
SUB02209MIG · Substance
- Active substance
- Fludrocortisone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2562 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07684MIG · Substance
- Active substance
- Fludrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2562 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01608MIG · Substance
- Active substance
- Dexamethasone Acetate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2562 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2562 mg milligram(s)
- Max treatment duration
- 42 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- POWDER FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08065MIG · Substance
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Jelena Todoric
Third parties 7
| Organisation | City, country | Duties |
|---|---|---|
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| Ardena Bioanalysis B.V. ORG-100036987
|
Assen, Netherlands | Laboratory analysis |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Guardant Health Inc. ORG-100042461
|
Redwood City, United States | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
Locations
15 EU/EEA countries · 72 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 40 | 5 |
| Estonia | Ongoing, recruiting | 15 | 4 |
| France | Ongoing, recruiting | 75 | 10 |
| Germany | Ongoing, recruiting | 55 | 11 |
| Greece | Ongoing, recruiting | 18 | 2 |
| Hungary | Ongoing, recruiting | 25 | 4 |
| Ireland | Ongoing, recruiting | 15 | 2 |
| Italy | Ongoing, recruiting | 20 | 6 |
| Latvia | Ongoing, recruiting | 12 | 2 |
| Lithuania | Ongoing, recruiting | 12 | 2 |
| Portugal | Ongoing, recruiting | 20 | 6 |
| Romania | Ongoing, recruiting | 20 | 5 |
| Slovakia | Ongoing, recruiting | 24 | 3 |
| Spain | Ongoing, recruiting | 40 | 8 |
| Sweden | Ongoing, recruiting | 10 | 2 |
| Rest of world
Chile, Thailand, Japan, Guatemala, Canada, Taiwan, Malaysia, United States, Colombia, United Kingdom, New Zealand, China, Australia, Israel, Peru, Puerto Rico, Costa Rica, Hong Kong, Singapore, Mexico, South Africa, Brazil, Korea, Republic of, Turkey
|
— | 1,076 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
Onkologická klinika, Karlovo Namesti 554/32, Nove Mesto, Prague 2
University Hospital Olomouc
Onkologická klinika FN Olomouc, Zdravotniku 248/7, 779 00, Olomouc
Masarykuv Onkologicky Ustav
Klinika komplexní onkologické péče, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Fakultni Nemocnice V Motole
Onkologická klinika 2. LF UK a FN Motol, V Uvalu 84/1, Motol, Prague 5
Fakultni Nemocnice U Sv Anny V Brne
Oddělení onkologicko-chirurgicke A1, Pekarska 53, Stare Brno, Brno-Stred
Sihtasutus Parnu Haigla
Surgery Clinic, Ristiku Tn 1, 80010, Parnu Linn
North Estonia Medical Centre Foundation
Oncology and Hematology Clinic, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
East Tallinn Central Hospital
Centre of Oncology, Parnu Mnt 104, Kesklinna Linnaosa, Tallinn
Tartu University Hospital
Haematology and Oncology Clinic, Radio- and oncotherapy Centre, A006, L. Puusepa Tn 8, Tartu Linn
Hospital Foch
Oncology, 40 Rue Worth, 92150, Suresnes
Les Hopitaux Universitaires De Strasbourg
Medical Oncology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
HPM Nord
Centre de Radiothérapie et d'Oncologie Bourgogne, 44 Avenue Marx Dormoy, 59000, Lille
Centre Jean Perrin
Oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centre Hospitalier Regional Et Universitaire De Brest
Oncology, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Capio La Croix Du Sud
Oncology, 52 Chemin De Ribaute, 31130, Quint-Fonsegrives
Centre Leon Berard
Oncology, 28 Rue Laennec, 69008, Lyon
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Oncology, 185 Rue Raymond Losserand, 75014, Paris
Institut Bergonie
Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Institut Gustave Roussy
Medical Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif
Urologicum Duisburg
Urologicum Duisburg, Fahrner Str 123, 47169, Duisburg
Universitaetsmedizin Goettingen
Klinik für Urologie, Robert-Koch-Strasse 40, Weende, Goettingen
Klinikum rechts der Isar der TU Muenchen AöR
Urologische Klinik und Poliklinik, Ismaninger Strasse 22, Au-Haidhausen, Munich
Medical Center - University Of Freiburg
Klinik für Urologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
University Hospital Cologne AöR
Klinik für Urologie, Uro-Onkologie spezielle urologische und roboter-assistierte Chirurgie Poliklini, Kerpener Strasse 62, Lindenthal, Cologne
Charite Universitaetsmedizin Berlin KöR
Klinik für urologie, Chariteplatz 1, Mitte, Berlin
National Center For Tumor Diseases (NCT) Heidelberg
National Center For Tumor Diseases (NCT) Heidelberg. Klinik f. Medizinische Onkologi, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
St. Marien-Krankenhaus GmbH
Urologie u. Kinderurologie, Dr.-Robert-Koch-Strasse 18, Gladbach, Bergisch Gladbach
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Urologie, Dieffenbachstrasse 1/1, Kreuzberg, Berlin
Universitaetsklinikum Regensburg AöR
Klinik für Urologie, Landshuter Strasse 65, Kasernenviertel, Regensburg
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
NA, Steinengrabenstrasse 17, 72622, Nuertingen
Alexandra Hospital
Oncology-Hematology department, Unit of Plasma cell dyscrasias, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Attikon
2nd Propaedeutic Department of Medicine, Rimini Street 1, 124 62, Athens
Szent Lazar Megyei Korhaz
Onkológia és Sugárterápiás Osztály, Fuleki Ut 54-56, 3100, Salgotarjan
University Of Debrecen
Onkológiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Orszagos Onkologiai Intezet
Urogenitális Tumorok és Klinikai Farmakológiai Osztály ,,Kemoterápia C”, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Klinikai Onkológiai és Sugárterápiás Centrum, Szentpeteri Kapu 72-76, 3526, Miskolc
Tallaght University Hospital
Oncology, Tallaght, D24 NR0A, Dublin 24
St Vincent's University Hospital
Oncology, Elm Park Merrion Road, D04 T6F4, Dublin 4
Azienda Ospedaliera S Maria Di Terni
S.C. Oncologia Medica e Traslazionale, Viale Tristano Di Joannuccio 1, 05100, Terni
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero Universitaria Ospedali Riuniti
Oncologia Medica e Terapia Biomolecolare, Viale Luigi Pinto 1, 71122, Foggia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Ospedale San Raffaele S.r.l.
Oncologia Medica, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Per L'Emergenza Cannizzaro
U.O.C di Oncologia Medica, Via Messina 829, 95126, Catania
Pauls Stradins Clinical University Hospital
Urology Center, Pilsonu Iela 13, 1002, Riga
Liepajas Regionala Slimnica SIA
NA, Slimnicas Iela 25, 3414, Liepaja
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Urology Clinic, Eiveniu G. 2, Kauno M. Sav., Kaunas
Viesosios istaigos Vilniaus universiteto ligonines Santaros kliniku filialas Nacionalinis vezio centras
., Santariskiu G. 1, Vilniaus M. Sav., Vilnius
Unidade Local De Saude De Santa Maria E.P.E.
Medical Oncology, Avenida Professor Egas Moniz, 1649-035, Lisbon
CCAB Centro Clinico Academico Braga Associacao
CCAB - Centro Clinico Académico Braga Associação, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Santo Antonio E.P.E.
Oncology Service, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude De Gaia/Espinho E.P.E.
Medical Oncology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Galo Saude Parcerias Cascais S.A.
Medical Oncology, Avenida Brigadeiro Victor Novais Goncalves, Cobre, Cascais
Hospital Cuf Tejo S.A.
Medical Oncology and Hematology, Avenida 24 De Julho 171a, 1350-345, Lisbon
Spitalul Clinic Municipal Cluj-Napoca
Departament Oncologie, Strada Tabacarilor 11, 400136, Cluj-Napoca
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Oncologie Medicala, 149th Ic Bratianu Street, 077015, Balotesti
Spitalul Clinic Prof.Dr.Theodor Burghele
Urologie, Panduri Road 20, District 5, Bucharest
Centrul De Oncologie SF Nectarie S.R.L.
Departament Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
Delta Health Care S.R.L.
Departament Oncologie, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Uroexam spol. s r.o.
Urologická ambulancia, Spitalska 13, 949 01, Nitra 1
Privatna Urologicka Ambulancia s.r.o.
Privatna Urologicka Ambulancia s.r.o., Piaristicka 7834/19, 911 01, Trencin
Narodny Onkologicky Ustav
II. onkologická klinika LF UK a NOÚ,Oddelenie klinickej onkológie D, Klenova 1, Nove Mesto, Bratislava
Hospital Quironsalud Malaga
Oncology, Avenida Imperio Argentina 1, 29004, Malaga
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitari De Girona Doctor Josep Trueta
Medical Oncology, Avinguda De Franca S/n, 17007, Girona
Complejo Hospitalario Universitario Insular Materno Infantil
Medical Oncology, Autovia Del Sur S/n, 35017, Las Palmas De Gran Canaria
Hospital Universitario Quironsalud Madrid
Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Complexo Hospitalario Universitario A Coruna
Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario De Burgos
Oncología, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Clinic De Barcelona
Oncology, Calle Villarroel 170, 08036, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2024-04-17 | 2024-05-06 | |||
| Estonia | 2024-05-06 | 2024-09-19 | |||
| France | 2024-04-05 | 2024-06-05 | |||
| Germany | 2024-04-08 | 2024-04-16 | |||
| Greece | 2024-05-27 | 2024-09-18 | |||
| Hungary | 2024-05-03 | 2024-05-31 | |||
| Ireland | 2024-05-09 | 2024-05-15 | |||
| Italy | 2024-04-30 | 2024-07-03 | |||
| Latvia | 2024-06-18 | 2024-07-11 | |||
| Lithuania | 2024-05-31 | 2024-07-10 | |||
| Portugal | 2024-04-11 | 2024-04-16 | |||
| Romania | 2024-04-12 | 2024-05-09 | |||
| Slovakia | 2024-05-24 | 2024-05-28 | |||
| Spain | 2024-04-05 | 2024-06-24 | |||
| Sweden | 2024-04-26 | 2024-07-23 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 15 · Art. 38 CTR
Temporary halt TH-93418
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Germany
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93432
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Portugal
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93422
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Hungary
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93434
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Romania
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93412
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Czechia
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93424
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Ireland
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93436
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Spain
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93414
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Estonia
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93426
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Italy
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93438
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Sweden
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93416
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- France
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93428
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Latvia
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93440
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Slovakia
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93430
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Lithuania
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-93420
- Halt date
- 2025-08-06
- Planned restart
- 2025-11-10
- Member states concerned
- Greece
- Publication date
- 2025-08-06
- Reason
- Study management related
- Explanation
- The MK-5684-004 trial has been placed on temporary enrollment pause. The study enrollment is progressing ahead of target, and the pause is necessary to assess the AR LBD status for randomized participants. The enrollment pause is not related to safety concerns. All participants who have initiated screening by this date will still have the opportunity to be randomized. The trial will restart after assessment is completed.
- Follow-up measures
- n/a
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 178 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-504957-11_GRC_EL_SM13_for pub | 08R |
| Protocol (for publication) | D1_Protocol_2023-504957-11_SM13_for pub | 08R |
| Protocol (for publication) | D4_Copyright statement_Analgesic Log_BPI-SF_EN_SM12_for pub | 04DEC2024 |
| Protocol (for publication) | D4_Copyright statement_EQ-5D-5L_FACT-P_EN_SM12_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_CZE_CS_for pub | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_DEU_EN_SM12_for pub | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ESP_ES_for pub | 27OCT2023R |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_EST_EN_for pub | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_SM12_for pub | 30JUN2025 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_GRC_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_for pub | outofscope |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ITA_EN_SM12_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LTU_LT_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_LVA_EN_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_PRT_EN_SM13_for pub | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_ROU_RO_for pub | 10MAY2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SVK_SK_for pub | 26OCT2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_SWE_SV_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IRL_EN_SM12_for pub | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Brochure_HUN_HU_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Clinical Trial Brochure_CZE_CS_for pub | v001 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_DEU_DE_for pub | v00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_EST_ET_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_EST_RU_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_HUN_HU_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_IRL_EN_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_LTU_LT_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_LTU_RU_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_LVA_LV_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_LVA_RU_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_ROU_RO_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_SWE_SV_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_DEU_DE_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_EST_ET_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_EST_RU_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_IRL_EN_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_LTU_LT_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_LTU_RU_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_LVA_LV_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_LVA_RU_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ROU_RO_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_SWE_SV_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_DEU_DE_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_GRC_EL_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_PRT_PT_for pub | 00-1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Study Card_DEU_DE_for pub | 00.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Summary PIS_IRL_EN_SM12_for pub | 2.00 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Adrenal Insufficiency Reference Guide_GRC_EL_for pub | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Kit Checklist Oral Hydrocort_GRC_EL_for pub | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Emergency Kit Oral IM Hydrocort_GRC_EL_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Adrenal Insufficiency Crisis Card_CZE_CS_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Adrenal Insufficiency Crisis Card_SVK_SK_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Emergency Kit Instructions_CZE_CS_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Emergency Kit Instructions_SVK_SK_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_HU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_PRT_EN_SM12_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_PRT_PT_SM12_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent adult_GRC_EL_SM13-RFI001_for pub | AM03_3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_SM13_for pub | 5R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_DEU_DE_SM13-RFI004_for pub | AM03 v3R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM13_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_EST_ET_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_EST_RU_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_SM13_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM13_for pub | AM03v3.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_IRL_EN_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LTU_LT_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LTU_RU_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LVA_LV_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_LVA_RU_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_EN_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_EN_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_PT_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_EN_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ROU_RO_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SVK_SK_SM13-RFI006_for pub | 7R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_SWE_SV_SM13_for pub | AM03v3.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_SM12_for pub | 13JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_for pub | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_SVK_SK_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_add crossborder_DEU_DE_SM12_for pub | 1.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_ClinCard_SWE_SV_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_data privacy_limited screening_ITA_IT_SM12_for pub | 27JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_SM12_for pub | 13JUN2025 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_EST_ET_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_EST_RU_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_GRC_EL_SM12_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_IRL_EN_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_LTU_LT_SM12-RFI010_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_LTU_RU_SM12-RFI010_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_LVA_LV_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_LVA_RU_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_PRT_PT_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_ROU_EN_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_ROU_RO_SM12_for pub | AM01v1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_CZE_CS_SM13_for pub | 2R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_DEU_DE_SM13_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ESP_ES_SM13_for pub | 01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_EST_ET_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_EST_RU_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_FRA_FR_SM13_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_GRC_EL_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_HUN_HU_SM13_for pub | 0.01R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_IRL_EN_SM13_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ITA_IT_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_LTU_LT_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_LTU_RU_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_LVA_LV_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_LVA_RU_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_PRT_PT_SM13_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ROU_EN_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_ROU_RO_SM13_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_SVK_SK_SM13-RFI006_for pub | 2R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_limited screening consent_SWE_SV_SM13_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_PRT_PT_SM12_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_SVK_SK_for pub | sk v2 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_withdrawal_PRT_PT_SM12_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Summary_IRL_EN_for pub | 1.00 |
| Subject information and informed consent form (for publication) | L1_Participant Steroid Emergency Card_CZE_CS_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Participant Steroid Emergency Card_SVK_SK_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_ClinCard Generic Image_GRC_EN_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_ConneX Travel Contact Card_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_GRC_EL_for pub | 1.0_00_1.2 |
| Subject information and informed consent form (for publication) | L1_Patient emergency card_Adrenal Insufficiency Crisis_GRC_EL_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient emergency card_PRT_PT_for pub | 1-0 |
| Subject information and informed consent form (for publication) | L1_Patient emergency card_Steroid_GRC_EL_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_HUN_HU_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_SVK_SK_for pub | 1.0001.1R |
| Subject information and informed consent form (for publication) | L1_Patient Infor Leaflet_ClinCard Cardholder Message Templates_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Infor Leaflet_ClinCard_Bank Transf Standard Messag_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Infor Leaflet_ConneX Travel Guide for Participants_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Information Leaflet_ClinCard Bank Transfer FAQ_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Information Leaflet_ClinCard Cardholder FAQ_GRC_EL_for pub | 11.0 |
| Subject information and informed consent form (for publication) | L1_Patient Information Leaflet_ClinCard Privacy Policy_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Information Leaflet_ClinCard_3D Secure Terms of Use_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient Information Leaflet_ClinCard_KYC_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Adrenal Crisis Card_LVA_LV_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Adrenal Crisis Card_LVA_RU_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Instructions_ClinCard Card Carrier_GRC_EL_for pub | 10.2 |
| Subject information and informed consent form (for publication) | L1_Patient Instructions_ClinCard Fee Schedule_GRC_EL_for pub | 10.1 |
| Subject information and informed consent form (for publication) | L1_Patient Instructions_ClinCard_EU Dispute Form_GRC_EL_for pub | 10.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Emergency Kit Instruction with inj_LVA_LV_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Emergency Kit Instruction with inj_LVA_RU_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Emergency Kit Instruction_LVA_LV_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Emergency Kit Instruction_LVA_RU_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Emergency Kit_GRC_EL_for pub | 2.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Steroid Emengency Card_LVA_LV_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient instructions_Steroid Emengency Card_LVA_RU_for pub | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient thank you card_GRC_EL_for pub | 00.1 |
| Subject information and informed consent form (for publication) | L1_Patient visit scheme_Calendar_GRC_EL_for pub | 00.1 |
| Subject information and informed consent form (for publication) | x_L1_Patient ID Card_CZE_CS_for pub | 29NOV2012R |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_ENZALUTAMIDE_Astellas Pharma Ltd_SM13_for pub | 04SEP2025 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_PREDNISOLONE Amdipharm Mercury Co_SM12_for pub | 12Apr2024 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC RSI_Prednisone_Tablets_EN_for pub | 01MAR2022 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC RSI_Abiraterone_for pub | Janssen |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_DEU_DE_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_ESP_ES_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_GRC_EL_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_HUN_HU_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_IRL_EN_SM12_for pub | 3.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_ITA_IT_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_PRT_PT_SM13_for pub | 4 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_ROU_RO_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2023-504957-11_SWE_SV_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_202350495711_CZE_CS_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_202350495711_SVK_SK_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_FRA_FR_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_LTU_LT_SM13_for pub | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-504957-11_HUN_HU_for pub | 0.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-504957-11_PRT_PT_SM12_for pub | 03 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-504957-11_ROU_RO_SM13_for pub | 08R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2023-504957-11_SVK_SK_SM12_for pub | 2.0R |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_CZE_CS_SM13_for pub | 3R |
Application history
15 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | France | Acceptable 2024-03-18
|
2024-03-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-17 | France | Acceptable 2024-09-05
|
2024-09-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-01 | Acceptable | 2024-10-31 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-02 | France | Acceptable | 2024-10-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-02 | Acceptable | 2024-11-26 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-16 | France | Acceptable | 2025-01-09 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-17 | Acceptable | 2024-12-18 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-02-13 | Acceptable | 2025-04-29 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-02-17 | Acceptable | 2025-03-31 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-17 | Acceptable | 2025-03-26 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-02-17 | Acceptable | 2025-04-22 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-03-11 | France | Acceptable | 2025-04-03 |
| 13 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-05 | France | Acceptable 2025-11-07
|
2025-11-08 |
| 14 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-12-04 | France | Acceptable 2026-03-23
|
2026-03-24 |
| 15 | SUBSTANTIAL MODIFICATION | SM-14 | 2026-05-05 | Acceptable | 2026-05-18 |