Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
960
Countries
12
Sites
95
Metastatic Castration-resistant Prostate Cancer (mCRPC)
The main goal of this study is to see if a new medicine called BMS-986365 works better than another doctor's chosen treatment. This will be measured by looking at how long it takes for the patient's disease to get worse.
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 May 2025 → ongoing
- Decision date (initial)
- 2025-05-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Celgene Corporation
External identifiers
- EU CT number
- 2024-517422-25-00
- WHO UTN
- U1111-1311-0532
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacodynamic, Pharmacokinetic
The main goal of this study is to see if a new medicine called BMS-986365 works better than another doctor's chosen treatment. This will be measured by looking at how long it takes for the patient's disease to get worse.
Secondary objectives 5
- To compare BMS-986365 with the doctor's chosen treatment. It will measure success by looking at how long the patients live after starting the treatment.
- Assessing the dose of BMS-986365 that presents the best benefitrisk profile (= being able to control the cancer while keeping a good tolerance)
- Evaluating the level of the drug in the blood
- Evaluating other biological markers to see how effective is the drug
- Evaluating the tolerance and impact of study drugs on symptoms, overall health and quality of life.
Conditions and MedDRA coding
Metastatic Castration-resistant Prostate Cancer (mCRPC)
| 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, U.S. Food And Drug Administration
- Plan to share IPD
- Yes
- IPD plan description
- BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Men who are 18 years or older with a certain type of advanced prostate cancer that is getting worse.
- Men who have signs of the cancer spreading to other parts of their body, which can be seen on special scans like a bone scan or a CT/MRI scan.
- Questionnaires will be filled out by the participant to ensure they are not suffering too much from their prostate cancer symptoms.
- Participants should have also tried certain treatments before, like abiraterone, enzalutamide, apalutamide, or darolutamide, which are medicines used to treat prostate cancer.
Exclusion criteria 2
- There are some conditions that exclude from participation like heart problems or serious heart disease.
- Also, if the cancer has spread to the brain or liver, or if a special type of bone scan called a Tc-99m superscan shows too much cancer spread, then the man can't join the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- rPFS (for radiographic progression-free survival) by BICR (Blinded Independent Central Review). The ability of BMS-986365 to work better than other treatments chosen by the doctors is tested by looking at the rPFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like X-rays or scans)
Secondary endpoints 1
- OS (Overall Survival) This study will assess if people live longer when they take BMS-986365 compared to other treatments chosen by the doctors. This is what is called "Overall Survival".
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11788662 · Product
- Active substance
- BMS-986365
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 9999 Other
- Max total dose
- 9999 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 7
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(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 USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12492MIG · Substance
- Active substance
- Docetaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 9999 mg/m2 milligram(s)/sq. meter
- Max total dose
- 9999 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07361MIG · Substance
- Active substance
- Abiraterone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07361MIG · Substance
- Active substance
- Abiraterone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(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
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 9999 mg milligram(s)
- Max total dose
- 9999 mg milligram(s)
- Max treatment duration
- 9999 Week(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
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- Celgene Corporation
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- Celgene Corporation
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other |
| Foundation Medicine Inc. ORG-100040457
|
Cambridge, United States | Other |
| QPS LLC ORG-100012847
|
Newark, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Nordic Bioscience A/S ORG-100009315
|
Herlev, Denmark | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
Locations
12 EU/EEA countries · 95 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 18 | 4 |
| Czechia | Ongoing, recruiting | 28 | 7 |
| Denmark | Ongoing, recruiting | 20 | 4 |
| France | Ongoing, recruiting | 36 | 11 |
| Germany | Ongoing, recruiting | 48 | 14 |
| Ireland | Ongoing, recruiting | 13 | 3 |
| Italy | Ongoing, recruiting | 35 | 11 |
| Poland | Ongoing, recruiting | 39 | 8 |
| Romania | Ongoing, recruiting | 25 | 5 |
| Slovakia | Ongoing, recruiting | 16 | 4 |
| Spain | Ongoing, recruiting | 73 | 20 |
| Sweden | Ongoing, recruiting | 23 | 4 |
| Rest of world
United States, Chile, Korea, Republic of, United Kingdom, China, Argentina, Japan, Brazil, Taiwan, Australia, Canada, India
|
— | 586 | — |
Investigational sites
Medical University Of Vienna
University Clinic for Urology, Waehringer Guertel 18-20, Alsergrund, Vienna
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
University Clinic for Urology and Andrology, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Department of Urology, Fadingerstrasse 1, 4020, Linz
Universitaetsklinikum Krems
Clinical Department of Internal Medicine 2, Mitterweg 10, 3500, Krems An Der Donau
Fakultni Nemocnice V Motole
Onkologicka klinika, V Uvalu 84/1, Motol, Prague
Fakultni Thomayerova nemocnice
Onkologicka klinika, Videnska 750/800, Krc, Prague
Masarykuv Onkologicky Ustav
Klinika komplexni onkologicke pece, Zluty Kopec 543/7, Stare Brno, Brno-Stred
Urocentrum Praha s.r.o.
NA, Karlovo Namesti 319/3, Nove Mesto, Prague
University Hospital Olomouc
Onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Vseobecna Fakultni Nemocnice V Praze
Onkologicka klinika, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
Klinika onkologie a radioterapie, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Rigshospitalet
Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Region Hovedstaden
Urology, Borgmester Ib Juuls Vej 1, 2730, Herlev
Aarhus University Hospital
Oncology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Oncology, Hobrovej 18-22, 9000, Aalborg
Oncopole Claudius Regaud
Oncologie Médicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Antoine Lacassagne
Oncologie Médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Centr Georges Francois Leclerc
Oncologie Médicale, 1 Rue Professeur Marion, 21000, Dijon
Institut De Cancerologie De Lorraine
Oncologie Médicale, 6 Avenue De Bourgogne, 54500, Vandouvre Les Nancy
Institut Gustave Roussy
Oncologie Médicale, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Jean Perrin
Oncologie, 58 Rue Montalembert, 63000, Clermont-Ferrand
Clinique Victor Hugo
Oncologie Radiothérapie, Centre De Cancerologie De La Sarthe, 66 Rue De Degre, Le Mans
Centre Hospitalier Prive Saint-Gregoire
Oncologie Médicale, 6 Boulevard De La Boutiere, Cs 56816, Saint-Gregoire
Hospices Civils De Lyon
Oncologie Médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Les Hopitaux Universitaires De Strasbourg
Oncologie Médicale, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Institut De Cancerologie Strasbourg Europe
Oncologie Médicale, 3 Rue De La Porte De L Hopital, 67065, Strasbourg Cedex
St. Marien-Krankenhaus GmbH
Urologie & Kinderurologie - Studienzentrum, Dr.-Robert-Koch-Strasse 18, Gladbach, Bergisch Gladbach
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Klinik für Urologie, Hoelkeskampring 40, Herne-Sued, Herne
Urologisches Zentrum Mittelhessen - Praxis Biedenkopf
Studien, Obermühlsweg 1, 35216, Biedenkopf
Universitaetsklinikum Jena KöR
Klinik und Poliklinik für Urologie, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Heidelberg AöR
Abt. Medizinische Onkologie, Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Studienzentrum, Steinengrabenstrasse 17, 72622, Nuertingen
Universitaetsklinikum Wuerzburg AöR
Klinik und Poliklinik für Urologie und Kinderurologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Urologie, Ratzeburger Allee 160, 23538, Luebeck
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Bonn AöR
Klinik und Poliklinik für Urologie und Kinderurologie, Venusberg-Campus 1, Venusberg, Bonn
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik für Urologie, Ismaninger Strasse 22, Au-Haidhausen, Munich
Urologicum Duisburg
Studienzentrum, Fahrner Str 123, 47169, Duisburg
Universitaetsklinikum Tuebingen AöR
Universitätsklinik für Urologie, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Universitaetsklinikum Essen AöR
Klinik für Urologie, Hufelandstrasse 55, Holsterhausen, Essen
Beaumont Hospital
Medical Oncology, Beaumont Road, Beaumont, Dublin 9
Tallaght University Hospital
Medical Oncology, Tallaght, D24 NR0A, Dublin 24
Cork University Hospital
Medical Oncology, Wilton, T12 DC4A, Cork
Istituto Oncologico Veneto
Oncologia Medica 1, Via Gattamelata 64, 35128, Padova
I.F.O. Istituti Fisioterapici Ospitalieri
Oncologia Medica, Via Elio Chianesi N 53, 00144, Rome
San Raffaele Hospital
Oncologia Medica, Via Olgettina 58, 20132, Milan
Azienda Ospedaliero Universitaria Ospedali Riuniti
Oncologia Medica E Terapia Biomolecolare, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliera Per L'Emergenza Cannizzaro
UOC Oncologia Medica, Via Messina 829, 95126, Catania
Azienda Ospedaliera S Maria Di Terni
Oncologia Medica e Translazionale, Viale Tristano Di Joannuccio 1, 05100, Terni
Azienda Unita' Sanitaria Locale Toscana Sud Est
Oncologia Medica, Ospedale Area Aretina Nord, Via Pietro Nenni 20/22, Arezzo
Azienda Provinciale Per I Servizi Sanitari
Oncologia Medica, Largo Medaglie D'oro 9, 38122, Trento
Istituto Nazionale Dei Tumori
Oncologia Medica, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Oncologia Medica, Regione Gonzole 10, 10043, Orbassano
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncologia Clinica Sperimentale Uro-Ginecologica, Via Mariano Semmola 52, 80131, Naples
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Oddział Terapii Izotopowej, Ul. Woloska 137, 02-507, Warsaw
Polimed Specjalistyczna Przychodnia Lekarska
n/a, Pl. Powstancow Slaskich 1/116, 53-329, Wroclaw
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Klinika Onkologii z Odcinkiem Dziennym, Ul. Katowicka 66a, 45-061, Opole
Copernicus Podmiot Leczniczy Sp. z o.o.
Wojewodzkie Centrum Onkologii Oddzial Onkologii Klinicznej/ Chemioterapii, Al. Zwyciestwa 31/32, 80-219, Gdansk
Pratia S.A.
Pratia Poznan, Ul. Gryfinska 1, 60-192, Poznan
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
Ambulatorium Chemioterapii, Ul. Izabeli Romanowskiej 2, 85-796, Bydgoszcz
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Oddział Onkologii Klinicznej, Aleja Legionow 10, 41-902, Bytom
Institutul Regional De Oncologie Iasi
Oncologie Medicala, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Oncologie Medicala, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Municipal Ploiesti
Oncologie Medicala, Strada Ipatescu Ana Nr 59, 100337, Ploiesti
Centrul De Oncologie SF Nectarie S.R.L.
Oncologie Medicala, Strada Caracal Nr 109, 200542, Craiova
CF Clinical Hospital
Oncologie Medicala, Strada Republicii 18, 400015, Cluj-Napoca
Milab s.r.o.
Urology, Jana Holleho 14/d, 080 01, Presov
Urologia s.r.o.
Urologia, Kollarova 17a, 036 01, Martin
F D Roosevelt University General Hospital Of Banska Bystrica
Oncology, Namestie Ludvika Svobodu 1, 974 01, Banska Bystrica
Narodny Onkologicky Ustav
Oncology, Klenova 1, Nove Mesto, Bratislava
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario De Navarra
Oncology, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Reina Sofia
Oncology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Ramon Y Cajal
Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Lucus Augusti
Oncology, Rua Dr. Ulises Romero 1, 27003, Lugo
Hospital Universitario De Badajoz
Oncology, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario De Burgos
Oncology, Avenida De Las Islas Baleares 3, 09006, Burgos
University Hospital Virgen Del Rocio S.L.
Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Parc Tauli Hospital Universitari
Oncology, Parc Del Tauli 1, 08208, Sabadell
Hospital Clinico San Carlos
Oncology, Calle De Martin Fierro Sn, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Complejo Hospitalario Universitario De Ourense
Oncology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
Hospital Universitario Virgen De La Macarena
Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Vithas La Salud
Oncology, Avenida De Santa Maria De La Alhambra Sn, 18008, Granada
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario De Cruces
Oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Karolinska University Hospital
Medicinsk enhet Bäckencancer, urologisk onkologi, A5:01 Mottagning Urologiska sjukdomar, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
VO Hematologi, Onkologi och Strålningsfysik, Jan Waldenströmsgata 18, 205 02 Malmö, St. Johns, Fritz Bauers Gata 5, Malmo
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Onkologkliniken, Blå Stråket 2, 413 45 Göteborg, Bla Straket 5, Goteborgs Annedal, Goteborg
Uppsala University Hospital
Onkologkliniken, Akademiska Sjukhuset, 751 85, Uppsala
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 |
|---|---|---|---|---|---|
| Austria | 2025-05-22 | 2025-07-01 | |||
| Czechia | 2025-06-10 | 2025-06-20 | |||
| Denmark | 2025-05-23 | 2025-05-28 | |||
| France | 2025-06-10 | 2025-06-11 | |||
| Germany | 2025-05-22 | 2025-07-07 | |||
| Ireland | 2025-05-30 | 2025-07-09 | |||
| Italy | 2025-05-28 | 2025-06-03 | |||
| Poland | 2025-05-22 | 2025-05-29 | |||
| Romania | 2025-05-22 | 2025-05-29 | |||
| Slovakia | 2025-10-28 | 2025-11-04 | |||
| Spain | 2025-05-28 | 2025-05-28 | |||
| Sweden | 2025-05-30 | 2025-06-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 162 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517422-25-00_redacted | 01 |
| Protocol (for publication) | D1_Protocol Annex Satellite sites_SE_Redacted | 1 |
| Protocol (for publication) | D1_Statistical Analysis plan for CSR Blank | 1 |
| Protocol (for publication) | D4_Patient facing documents_eCOA not for publication statement_CZ_CS_public | NA |
| Protocol (for publication) | D4_Patient facing documents_Statement on validated questionnaires under license_IT | 1 |
| Protocol (for publication) | D4_patient facing documents_statement_under license PL | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_Eng | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_FR | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_RO | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_AT_ger | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_DE_ger | NA |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_ES | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_SE | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under license_SK | 1 |
| Recruitment arrangements (for publication) | K Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements IT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CZ | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_SK | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment_Arrangement_AT_CA071-1000 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_material_PI-to-Patient Letter_AT_CA071-1000 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_material_Recruitment_Brochure_AT_CA071-1000 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_material_Recruitment_Poster_AT_CA071-1000 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI-to-Patient Letter Template_DE_ger | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI-to-Patient Letter_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_rechARge_RecruitmentBrochure_IE_ENG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure Template_DE_ger | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster Template_DE_ger | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Recruitment Brochure_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Recruitment Poster_RO | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Recruitment_Brochure_FR | 1 |
| Subject information and informed consent form - Extract (for publication) | CA071 1000 PART 2 IC Optional PD Biomarker assessment IC V1 27th Jan 2026_Redacted | 1 |
| Subject information and informed consent form - Extract (for publication) | L1SIS and ICF Main Part 2 V1 27Jan2026 Redacted | 1 |
| Subject information and informed consent form - Extract (for publication) | L1SIS and ICF Optional Dose Switch V1 27Jan2026_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main Part 2 redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Sample Collection Part 2 redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Optional Sample Collection Part 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-IC Add Right not to know | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-IC Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS-IC Optional Future Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1 SIS-IC Optional request archvial tumor samples_clean_redacted | 1 |
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| Subject information and informed consent form (for publication) | L1 SIS-IC Treatment Beyond Progression_clean | 2 |
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| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main Part 2_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Main_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional Future Research | 1 |
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| Subject information and informed consent form (for publication) | L1_ SIS and ICF Optional PK Sampling_Redacted | 2 |
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| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_IT_Redacted | 1 |
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| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Treatment Beyond Progression_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Dose Switch IC_IE_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2_IE_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Part 2_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_For Publication_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IE_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_IT v2_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biomarker Sample Collection IC_IE_ENG_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research IC_IE_ENG | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_Clean_No redaction | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PK Samples_FR_For Publication_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PK Sampling_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection Part 2_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Switch Dose_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Switch_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner IC_IE_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Beyond Progression IC_IE_ENG | 2.1 |
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| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Optional PD Biomarker Samples_Part 2_redacted_DE_ger | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_FR _Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dose Switch_redacted_DE_ger | 1 |
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| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Clean_SK_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1 - enrolled participant_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 1_CZ_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_redacted_DE_ger | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Part 2_SK_clean_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_clean_AT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part 2_clean_AT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part II_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Part2_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted_DE_ger | 03 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mother of the child born_clean_SK | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Opt Future Research_Clean_SK | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Opt Sample Collection_SK_clean_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Biomarker Sample Collection_Part II_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Dose Switch_CZ_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Dose Switch_IT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research | 2 |
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| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional PD Sample_Part 2_clean_AT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional PK_CZ_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_optional PK_redacted_DE_ger | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_Part2_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample Collection_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Sample_clean_AT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_clean_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnant partner_clean_DE_ger | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_Clean_SK | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_CZ_public | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_clean_AT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_treatment beyond progression_clean_DE_ger | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_Clean_SK | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Beyond Progression_CZ_public | 2.0 |
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| Subject information and informed consent form (for publication) | L1_Site Contact Details_AT_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1SIS and ICF Optional Dose Switch redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2 Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clean_SK | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Notice Payment Reimbursement_PL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PDP_CZ_public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC abiraterone RSI | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC abiraterone RSI_TC | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Docetaxel Bendalis | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Prednisolone Tablet_IE-RSI - Local sourcing | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmpC_Enzalutamide Adalvo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmpC_Enzalutamide Astellas | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_Enzalutamide Astellas _TC 2 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_Enzalutamide Astellas_Section 4_8_TC | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Prednisone acis DE_RSI | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Prednisone acis DE_RSI_TC | n/a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-517422-25_CZ_CS_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis POL 2024-517422-25_PL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ 2024-517422-25-00_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024_517422-25-00_SVK | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-517422-25_RO | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-517422-25-00_FR | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_Ger_2024-517422-25-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN 2024-517422-25-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-517422-25_Clean_SE | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU-CT 2024-517422-25_ES | 2 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-16 | Denmark | Acceptable 2025-04-30
|
2025-05-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-16 | Acceptable 2025-04-30
|
2025-05-16 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-05-20 | Acceptable 2025-04-30
|
2025-08-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-02 | Denmark | No conclusion 2025-12-08
|
2025-12-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-27 | Denmark | Acceptable 2026-03-25
|
2026-03-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-18 | Acceptable 2026-03-25
|
2026-05-18 |