A clinical trial to learn about the effects of AMO959 given with AAA617 and an androgen receptor pathway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body.athway inhibitor (ARPI) in adults with PSMA-positive prostate cancer that has spread to other parts of the body.

2025-521859-23-00 Protocol CAMO959A12103 Phase I and Phase II (Integrated) - Other Ongoing, recruiting

Start 31 Mar 2026 · Status Ongoing, recruiting · 4 EU/EEA countries · 18 sites · Protocol CAMO959A12103

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ongoing, recruiting
Participants planned 123
Countries 4
Sites 18

PSMA-positive mCRPC with prior exposure to at least one prior ARPI

Phase Ib: Escalation •To characterize the safety and tolerability of AMO959 in combination with AAA617 + ARPI and to determine the Recommended Dose for Expansion (RDE) Phase II •To evaluate the preliminary efficacy of AMO959 in combination with AAA617 + ARPI.

Key facts

Sponsor
Novartis Pharma AG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
31 Mar 2026 → ongoing
Decision date (initial)
2026-03-05
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Novartis Pharma AG

External identifiers

EU CT number
2025-521859-23-00
WHO UTN
U1111-1325-8180

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Therapy, Others, Pharmacodynamic, Pharmacokinetic, Efficacy

Phase Ib: Escalation
•To characterize the safety and tolerability of AMO959 in combination with AAA617 + ARPI and to determine the Recommended Dose for Expansion (RDE)
Phase II
•To evaluate the preliminary efficacy of AMO959 in combination with AAA617 + ARPI.

Secondary objectives 9

  1. To evaluate the preliminary efficacy of AMO959 in combination with AAA617 +/- ARPI and of AAA617 + ARPI.
  2. To evaluate the anti-tumor activity of AMO959 in combination with AAA617 +/- ARPI and of AAA617 + ARPI
  3. To characterize the PK of AMO959
  4. Only for Phase Ib: To characterize the PK of AAA617.
  5. Only for Phase Ib: To assess radiation dosimetry of AAA617 in organs and tumors.
  6. Only for Phase II: To evaluate the safety and tolerability of AMO959 in combination with AAA617 + ARPI and of AAA617 + ARPI.
  7. Only for Phase II: To evaluate the radiographic progression-free survival by PSMA PET/CT imaging (rPFS-PET) using approved PSMA agents of AMO959 in combination with AAA617 + ARPI and of AAA617 + ARPI.
  8. Only for Phase II: To evaluate health-related quality of life (HRQoL) and other patient reported outcomes (PROs).
  9. Only for Phase II: To evaluate the time to first symptomatic skeletal event (TTSSE).

Conditions and MedDRA coding

PSMA-positive mCRPC with prior exposure to at least one prior ARPI

VersionLevelCodeTermSystem organ class
26.1 PT 10062904 Hormone-refractory prostate cancer 100000004864
27.0 LLT 10086830 Hormone-refractory prostate cancer metastatic 100000004848

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Participants must be adults ≥ 18 years of age.
  3. Participants must have an ECOG performance status of 0 to 2.
  4. Participants must have histologically confirmed adenocarcinoma of the prostate. Participants with other histology (e.g. neuroendocrine, intraductal subtype) are not eligible.
  5. Phase Ib: Prior exposure of up to 1 line of taxane-based chemotherapy is permissible. Phase II: Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).
  6. Participants must have PSMA-PET positive disease assessed by using a PSMA imaging agent that is approved as per protocol and are eligible as determined by the sponsor’s central reading rules.
  7. Castration level of testosterone (< 50 ng/dL]), and/or use of concomitant androgen deprivation therapy ADT
  8. Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI), based on at least 1 of the following criteria: • Serum/plasma PSA progression is defined as 2 increases in PSA measured at least 1 week apart. The minimal start value is 2.0 ng/mL; 1.0 ng/mL is the minimal starting value if confirmed rise in PSA is the only indication of progression as per PCWG3 guidelines. • Soft-tissue progression defined PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016). • Progression of bone disease: 2 new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria Scher et al 2016).

Exclusion criteria 5

  1. Concurrent local (radiation therapy to the prostate with curative intent or other prostate antineoplastic ablative procedures) or systemic (hormonal ablation, chemotherapy, immunotherapy, XXX RLTs) antineoplastic treatments, or within 28 days of enrollment (Phase Ib) or randomization (Phase II)) or randomization (Phase II)
  2. Prior treatment with any RLT or PSMA-targeted agents (approved or investigational)
  3. Any other investigational agents within 28 days prior to first dose of any study treatment
  4. Concurrent serious medical conditions that may interfere with study procedures or follow-up
  5. Participants with a history of CNS metastases must have received therapy (surgery, whole brain radiation therapy, stereotactic radiosurgery) and be neurologically stable, asymptomatic, and not taking corticosteroids for the purpose of maintaining neurologic integrity.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

  1. Incidence of dose limiting toxicities (DLTs) with AMO959 in combination with AAA617 +/- ARPI during the first cycle (42 days from first dose of AAA617) of combination treatment
  2. Safety: Type, incidence and severity of AEs and SAEs, changes in laboratory values, and vital signs, and deaths
  3. Tolerability: Incidence of dose interruptions, reductions, and discontinuation; dose intensity and duration of exposure
  4. Biochemical response (PSA50), defined as the proportion of participants who achieved a ≥ 50% decrease in PSA from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥ 4 weeks later.

Secondary endpoints 9

  1. PSA90 is defined as the proportion of participants who achieved a ≥ 90% decrease from baseline at any time during the treatment period prior to start of new anti-cancer therapy that is confirmed by a second PSA measurement ≥ 4 weeks. Only for Phase Ib: PSA50 defined as above Only for Phase II: PSA50 in the AAA617 + ARPI arm as defined above
  2. rPFS: time from start of study treatment/randomization to radiographic PD/death ORR: proportion of participants with CR/PR DCR: proportion of participants with CR, PR, SD, Non-CR/Non-PD DoR: time from CR/PR to PD/death TTSTP: time from randomization to soft tissue PD OS: time from start of study treatment/randomization to death
  3. Plasma concentrations of AMO959 over time and derived PK parameters.
  4. Concentrations of AAA617 in blood over time and PK parameters from blood radioactivity data
  5. Time activity curves (TACs) and absorbed radiation doses in selected organs and tumor lesions.
  6. Safety: Type, incidence and severity of AEs and SAEs, changes in laboratory values, and vital signs, and deaths. Tolerability: Incidence of dose interruptions, reductions, and discontinuation; dose intensity and duration of exposure.
  7. rPFS-PET is defined as the time from the date of randomization to first documented radiographic disease progression (an increase in PSMA-positive tumor volume ≥ 20% from baseline and new PSMA-positive malignant lesions) as assessed by BICR using PSMA PET/CT imaging (Seifert et al 2023, Gafita et al 2023) or death due to any cause, whichever occurs first.
  8. Change from baseline in FACT-P Prostate Cancer Subscale (PCS) Time to worsening on the Worst Pain defined as the time from the date of randomization to the first occurrence of worsening on the Brief Pain Inventory – Short Form (BPI-SF) Worst Pain item of at least 30% increase from baseline or a minimum of 2 points increase from baseline or death due to any cause, whichever occurs first.
  9. TTSSE defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Abiraterone

SUB07361MIG · Substance

Active substance
Abiraterone
Pharmaceutical form
TABLET
Route of administration
ORAL
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

AMO959

PRD12731705 · Product

Active substance
AMO959
Pharmaceutical form
CAPSULE
Route of administration
OTHER USE
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

AMO959

PRD12731697 · Product

Active substance
AMO959
Pharmaceutical form
CAPSULE
Route of administration
OTHER USE
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

Enzalutamide

SUB77412 · Substance

Active substance
Enzalutamide
Pharmaceutical form
FILM COATED TABLETS
Route of administration
ORAL
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pluvicto 1 000 MBq/mL solution for injection/infusion

PRD10117052 · Product

Active substance
Lutetium (177LU) Vipivotide Tetraxetan
Substance synonyms
Lutetium Lu 177 vipivotide tetraxetan, 177LU-PSMA-617, VIPIVOTIDE TETRAXETAN LUTETIUM LU-177, LUTETIUM (177LU) PROSTATE-SPECIFIC MEMBRANE ANTIGEN, PSMA-617 LU-177
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Authorisation status
Authorised
ATC code
V10XX05 — -
Marketing authorisation
EU/1/22/1703/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enzalutamide

PRD12692376 · Product

Active substance
Enzalutamide
Substance synonyms
MDV3100
Pharmaceutical form
CAPSULE, SOFT
Route of administration
ORAL
Authorisation status
Not Authorised
ATC code
L02BB04 — -
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

Abiraterone

PRD12290812 · Product

Active substance
Abiraterone
Other product name
Abiraterone
Pharmaceutical form
TABLET
Route of administration
ORAL
Authorisation status
Not Authorised
MA holder
NOVARTIS PHARMA AG
Paediatric formulation
No
Orphan designation
No

Auxiliary 8

Prednison acis 5 mg

PRD889556 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
49572.00.00
MA holder
ACIS ARZNEIMITTEL GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Central sourcing by Novartis, vendors on behalf of Novartis, and/or site sourcing (Succeed project is applicable).

Prednison 5 mg GALEN® Tabletten

PRD784740 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
33644.00.00
MA holder
GALENPHARMA GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Central sourcing by Novartis, vendors on behalf of Novartis, and/or site sourcing (Succeed project is applicable).

Relugolix

SUB189168 · Substance

Active substance
Relugolix
Pharmaceutical form
FILM-COATED TABLET
Route of administration
UNKNOWN USE
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Sourcing will either be conducted through vendors on behalf of Novartis or locally by each investigator/site. Each AxMP will be labeled if required per country requirement when applicable.

Degarelix

SUB27748 · Substance

Active substance
Degarelix
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Route of administration
UNKNOWN USE
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Sourcing will either be conducted through vendors on behalf of Novartis or locally by each investigator/site. Each AxMP will be labeled if required per country requirement when applicable.

Degarelix

SUB27748 · Substance

Active substance
Degarelix
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Route of administration
UNKNOWN USE
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Sourcing will either be conducted through vendors on behalf of Novartis or locally by each investigator/site. Each AxMP will be labeled if required per country requirement when applicable.

Piflufolastat (18F)

SUB189818 · Substance

Active substance
Piflufolastat (18F)
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gozetotide

SUB219371 · Substance

Active substance
Gozetotide
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

L02AE · Product

Pharmaceutical form
PHF00243MIG
Route of administration
UNKNOWN USE
Authorisation status
Authorised
ATC code
L02AE — GONADOTROPIN RELEASING HORMONE ANALOGUES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Sourcing will either be conducted through vendors on behalf of Novartis or locally by each investigator/site. Each AxMP will be labeled if required per country requirement when applicable.

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

220 Total trials 69 Recruiting 130 Ended
Commercial
Sponsor organisation
Novartis Pharma AG
Address
Lichtstrasse 35
City
Basel
Postcode
4056
Country
Switzerland

Scientific contact point

Organisation
Novartis Pharma AG
Contact name
Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation
Novartis Pharma AG
Contact name
Novartis Pharma Arzneimittel GmbH

Third parties 16

OrganisationCity, countryDuties
Creapharm Clinical Supplies
ORG-100020131
 Le Haillan, France Code 14, Other
Jumo Health USA Inc.
ORG-100044054
 New Haven, United States Other
Syneos Health Inc.
ORG-100008382
 Morrisville, United States On site monitoring
Advanced Accelerator Applications Molecular Imaging Iberica S.L.
ORG-100043153
 Madrid, Spain Code 14
IQVIA Limited
ORG-100008655
 Reading, United Kingdom On site monitoring, Other, Interactive response technologies (IRT)
Scout Clinical
ORG-100042228
 Dallas, United States Other
Bioclinica Inc.
ORG-100033079
 Philadelphia, United States Other
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland On site monitoring
Icon Laboratory Services Inc.
ORG-100037135
 Farmingdale, United States Other, Laboratory analysis
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland Code 12
Veeda Clinical Research Limited
ORG-100012827
 Ahmedabad, India Other
Kayentis
ORG-100037894
 Meylan, France Other, E-data capture
Actigraph LLC
ORG-100043702
 Pensacola, United States Other
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Advanced Accelerator Applications Molecular Imaging Iberica S.L.
ORG-100043153
 Esplugues De Llobregat, Spain Code 14
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other

Locations

4 EU/EEA countries · 18 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 19 7
Germany Authorised, recruitment pending 19 4
Italy Authorised, recruitment pending 12 3
Spain Ongoing, recruiting 23 4
Rest of world
Japan, United States, China, Australia
 — 50 —

Investigational sites

France

7 sites · Ongoing, recruiting
Institut Gustave Roussy
2004: Nuclear Medicine, 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
2001: Medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Centre Hospitalier Universitaire De Nantes
2003: Medical oncology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire De Nantes
2003: Medical oncology, 9 Quai Moncousu, 44093, Nantes Cedex 1
Centre Hospitalier Universitaire De Nantes
2003: Medical oncology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Jean Perrin
2000: Medical oncology, 58 Rue Montalembert, 63000, Clermont-Ferrand
Centre Jean Perrin
2000: Medical oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1

Germany

4 sites · Authorised, recruitment pending
Klinikum Der Landeshauptstadt Stuttgart gKAöR
2102: Klinik für Nuklearmedizin, Kriegsbergstrasse 60, Mitte, Stuttgart
Universitaetsklinikum Essen AöR
2103: Klinik für Nuklearmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
2101: Klinik und Poliklinik für Urologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
2100: Klinik und Poliklinik für Nuklearmedizin, Ismaninger Strasse 22, Au-Haidhausen, Munich

Italy

3 sites · Authorised, recruitment pending
Fondazione IRCCS Istituto Nazionale Dei Tumori
2300: Oncologia Medica 1, Via Giacomo Venezian 1, 20133, Milan
University Hospital Of Ferrara
2301: Medicina Nucleare, Via Aldo Moro 8, 44124, Ferrara
IRCCS Istituto Nazionale Tumori Fondazione Pascale
2302: Oncologia Medica, Via Mariano Semmola 52, 80131, Naples

Spain

4 sites · Ongoing, recruiting
Hospital Universitario Virgen De Las Nieves
2203: Oncologia, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario 12 De Octubre
2200: Oncologia, Avenida De Cordoba Sn, 28041, Madrid
Hospital Clinic De Barcelona
2202: Oncologia, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
2201: Oncologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2026-05-04 2026-05-04
Spain 2026-03-31 2026-03-31

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 67 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol - Signature Page_2025-521859-23-00_1_English_Red V01-EU.01
Protocol (for publication) D1_Protocol_2025-521859-23-00_1_English_Red V01-EU.01
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_DE_English_NonRed V01
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed v5.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_FR_NonRed v00
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_IT_English_NonRed 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_1_IT_Italian_NonRed 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_2_FR_French_Red v00
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_2_IT_Italian_NonRed 1.1
Recruitment arrangements (for publication) K1_Recruitment Arrangements - Country_3_IT_Italian_NonRed 1.0
Recruitment arrangements (for publication) K2_Advertisements - Country_1_DE_German_NonRed V1.1
Recruitment arrangements (for publication) K2_Advertisements - Country_1_ES_Spanish_NonRed v1.1
Recruitment arrangements (for publication) K2_Advertisements - Country_1_FR_French_NonRed v1.1
Recruitment arrangements (for publication) K2_Advertisements - Country_2_DE_German_NonRed V0.0
Recruitment arrangements (for publication) K2_Advertisements - Country_2_ES_Spanish_NonRed v2.0
Recruitment arrangements (for publication) K2_Advertisements - Country_2_FR_French_Red 01
Recruitment arrangements (for publication) K2_Advertisements - Country_3_DE_German_NonRed v1.0
Recruitment arrangements (for publication) K2_Advertisements - Country_3_ES_Spanish_NonRed 21Jul2025
Recruitment arrangements (for publication) K2_Advertisements - Country_3_FR_French_NonRed 31Oct2025
Recruitment arrangements (for publication) K2_Advertisements - Country_4_ES_Spanish_NonRed 07Aug2025
Recruitment arrangements (for publication) K2_Advertisements - Country_4_FR_French_Red 01
Recruitment arrangements (for publication) K2_Advertisements - Country_5_ES_Spanish_NonRed v1.0
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant partner of participant_1_ES_Spanish_NonRed v00.00.00
Subject information and informed consent form (for publication) L1_ICF - Follow up for pregnant partner of participant_1_IT_Italian_NonRed 00.00.00
Subject information and informed consent form (for publication) L1_ICF - ICF - Optional treatment beyond disease progression_1_DE_German_Red v01.01.01
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_ES_Spanish_NonRed v00.00.00
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_FR_French_Red V00.00.00
Subject information and informed consent form (for publication) L1_ICF - Info Sheet Female Partner_1_IT_Italian_Red 00.00.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_DE_German_Red v01.01.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_ES_Spanish_Red v01.01.02
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_FR_French_Red V01.01.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_1_IT_Italian_Red 01.01.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_DE_German_Red v01.01.01
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_ES_Spanish_Red v01.01.02
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_FR_French_Red V01.01.00
Subject information and informed consent form (for publication) L1_ICF - Main ICF - Adult_2_IT_Italian_Red 01.01.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_DE_German_Red v01.01.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_ES_Spanish_Red v01.01.02
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_FR_French_NonRed V00.00.00
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_1_IT_Italian_NonRed 01.01.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_ES_Spanish_Red v01.01.02
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_2_IT_Italian_Red 01.01.01
Subject information and informed consent form (for publication) L1_ICF - Optional Assessment_3_ES_Spanish_NonRed v01.01.00
Subject information and informed consent form (for publication) L1_ICF - Optional1_1_FR_French_Red V00.00.00
Subject information and informed consent form (for publication) L1_ICF - Optional2_1_DE_German_Red v00.00.01
Subject information and informed consent form (for publication) L1_ICF - Optional2_1_FR_French_NonRed V00.00.00
Subject information and informed consent form (for publication) L1_ICF - Research_1_DE_German_Red v01.01.01
Subject information and informed consent form (for publication) L1_ICF Procedure_1_ES_Spanish_NonRed 21Jul2025
Subject information and informed consent form (for publication) L1_Subject Info Sheet or Other Info_1_FR_French_NonRed V00.00.00
Subject information and informed consent form (for publication) L2_ICF Procedure_1_DE_English_NonRed v00
Summary of Product Characteristics (SmPC) (for publication) E2_Reference AUSPI_1_Enzalutamide_English_NonRed 5Aug2024
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_AAA617_English_NonRed 20Oct25
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_Abiraterone_Accord_English_NonRed 19Aug25
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_Abiraterone_Medac_Italian_NonRed 12May22
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_Abiraterone_Zytiga_English_NonRed 18Oct24
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_Abiraterone_Zytiga_English_NonRed 18Oct24
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_Enzalutamide_English_NonRed 25Feb25
Summary of Product Characteristics (SmPC) (for publication) E2_Reference SmPC_1_Enzalutamide_English_NonRed 25Feb25
Summary of Product Characteristics (SmPC) (for publication) E2_Reference_USPI_1_Abiraterone_Amneal_English_NonRed 1Dec2023
Summary of Product Characteristics (SmPC) (for publication) E2_Reference_USPI_1_Abiraterone_Glenmark_English_NonRed 1May2022
Summary of Product Characteristics (SmPC) (for publication) E2_Reference_USPI_1_Abiraterone_Northstar_English_NonRed 1May2022
Summary of Product Characteristics (SmPC) (for publication) E2_Reference_USPI_1_Abiraterone_Zytiga_English_NonRed 1Dec2024
Summary of Product Characteristics (SmPC) (for publication) E2_Reference_USPI_2_Abiraterone_Amneal_English_NonRed 6Aug2023
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2025-521859-23-00_1_English_Red v01
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2025-521859-23-00_1_French_NonRed v01
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2025-521859-23-00_1_Italian_NonRed 00
Synopsis of the protocol (for publication) D1_Protocol Summary in Lay Language_2025-521859-23-00_1_Spanish_NonRed 00

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-11-11 Germany Acceptable
2026-03-04
 2026-03-05