Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
435
Countries
5
Sites
17
Prostate Cancer
To assess, in an independent assessment by 3 readers blinded to the clinical data, the sensitivity and specificity of [18F]PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in newly diagnosed high-risk and very-high-risk prostate cancer (region-based patient-level…
Key facts
- Sponsor
- Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jun 2024 → ongoing
- Decision date (initial)
- 2024-01-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
To assess, in an independent assessment by 3 readers blinded to the clinical data, the sensitivity and specificity of [18F]PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in newly diagnosed high-risk and very-high-risk prostate cancer (region-based patient-level analysis, at least one hemi-pelvis is correctly diagnosed), using histology as the standard of reference.
Conditions and MedDRA coding
Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- EMA paediatric investigation plan (PIP)
- EMEA-002918-PIP01-20
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504026-19-00 | Prospective, Multi-Center Study to Assess the Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients with Newly-Diagnosed High-Risk or Very-High-Risk Prostate Cancer | Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- The patient (male) is aged 18 years or above
- The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate
- The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment
- The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following: Overall ISUP grade group 4 or 5, OR Clinical category T3a or greater, –OR Serum PSA level greater than 20 ng/ml.
- The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure
Exclusion criteria 11
- Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection
- The patient has received any therapy – be it radiation, surgical or drug therapy – for his prostate cancer
- The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of [18F]PSMA-1007
- The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan)
- The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator
- At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit
- The patient has previously been enrolled in this trial
- Confidential commercial information
- The patient has histological evidence of small-cell carcinoma of the prostate
- The patient is clinically unstable or requires emergency treatment
- The patient is part of a vulnerable population, e.g., but not limited to the patient is incapacitated in such a way that renders him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Confidential commercial information
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
RADELUMIN 2000 MBq/ml solution injectable
PRD9769395 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 34009 550 897 4 2
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Radelumin 2000 MBq/ml oplossing voor injectie
PRD10368769 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- RVG 130644
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RADELUMIN 1300 MBq/ml solution injectable
PRD9391841 · Product
- Active substance
- (2S-2-1S-1-CARBOXY-5-2S-2-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18FFLUORANYLPYRIDINE-3-CARBONYLAMINOBUTANOYLAMINOBUTANOYLAMINOMETHYLBENZOYLAMINO-3-NAPHTHALEN-2-YLPROPANOYLAMINOPENTYLCARBAMOYLAMINOPENTANEDIOIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 34009 550 861 4 7
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RADELUMIN 1300 MBq/ml solution injectable
PRD9391842 · Product
- Active substance
- (2S-2-1S-1-CARBOXY-5-2S-2-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18FFLUORANYLPYRIDINE-3-CARBONYLAMINOBUTANOYLAMINOBUTANOYLAMINOMETHYLBENZOYLAMINO-3-NAPHTHALEN-2-YLPROPANOYLAMINOPENTYLCARBAMOYLAMINOPENTANEDIOIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 34009 550 861 5 4
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Radelumin 1300 MBq/ml Injektionslösung
PRD10911454 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Substance synonyms
- (2S)-2-[[(1S)-1-CARBOXY-5-[[(2S)-2-[[4-[[[(2S)-4-CARBOXY-2-[[(2S)-4-CARBOXY-2-[(6-(18F)FLUORANYLPYRIDINE-3-CARBONYL)AMINO]BUTANOYL]AMINO]BUTANOYL]AMINO]METHYL]BENZOYL]AMINO]-3-NAPHTHALEN-2-YLPROPANOYL]AMINO]PENTYL]CARBAMOYLAMINO]PENTANEDIOIC ACID, F-18-PSMA-1007, PSMA-1007 (18F), 18F-PSMA-1007, PSMA-1007 F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 7010953.00.00
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Radelumin 2000 MBq/ml Injektionslösung
PRD10911542 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Substance synonyms
- (2S)-2-[[(1S)-1-CARBOXY-5-[[(2S)-2-[[4-[[[(2S)-4-CARBOXY-2-[[(2S)-4-CARBOXY-2-[(6-(18F)FLUORANYLPYRIDINE-3-CARBONYL)AMINO]BUTANOYL]AMINO]BUTANOYL]AMINO]METHYL]BENZOYL]AMINO]-3-NAPHTHALEN-2-YLPROPANOYL]AMINO]PENTYL]CARBAMOYLAMINO]PENTANEDIOIC ACID, F-18-PSMA-1007, PSMA-1007 (18F), 18F-PSMA-1007, PSMA-1007 F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 7010954.00.00
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Radelumin 1300 MBq/mL solución inyectable
PRD10426309 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Substance synonyms
- (2S)-2-[[(1S)-1-carboxy-5-[[(2S)-2-[[4-[[[(2S)-4-carboxy-2-[[(2S)-4-carboxy-2-[(6-(18F)fluoranylpyridine-3-carbonyl)amino]butanoyl]amino]butanoyl]amino]methyl]benzoyl]amino]-3-naphthalen-2-ylpropanoyl]amino]pentyl]carbamoylamino]pentanedioic acid, F-18-PSMA-1007, PSMA-1007 (18F), 18F-PSMA-1007, PSMA-1007 F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 88792
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RADELUMIN 2000 MBq/ml solution injectable
PRD9769464 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 34009 550 897 5 9
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RADELUMIN 2000 MBq/ml solution injectable
PRD9769631 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 34009 550 897 6 6
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RADELUMIN 1300 MBq/ml solution injectable
PRD9390580 · Product
- Active substance
- (2S-2-1S-1-CARBOXY-5-2S-2-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18FFLUORANYLPYRIDINE-3-CARBONYLAMINOBUTANOYLAMINOBUTANOYLAMINOMETHYLBENZOYLAMINO-3-NAPHTHALEN-2-YLPROPANOYLAMINOPENTYLCARBAMOYLAMINOPENTANEDIOIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 34009 550 861 3 0
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Radelumin 2000 MBq/mL solución inyectable
PRD10426310 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Substance synonyms
- (2S)-2-[[(1S)-1-carboxy-5-[[(2S)-2-[[4-[[[(2S)-4-carboxy-2-[[(2S)-4-carboxy-2-[(6-(18F)fluoranylpyridine-3-carbonyl)amino]butanoyl]amino]butanoyl]amino]methyl]benzoyl]amino]-3-naphthalen-2-ylpropanoyl]amino]pentyl]carbamoylamino]pentanedioic acid, F-18-PSMA-1007, PSMA-1007 (18F), 18F-PSMA-1007, PSMA-1007 F-18
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- 88791
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Radelumin 1300 MBq/ml oplossing voor injectie
PRD10368768 · Product
- Active substance
- (3S10S14S-1-4-2S-4-CARBOXY-2-2S-4-CARBOXY-2-6-18F] FLUOROPYRIDIN-3-AMIDOBUTANAMIDOBUTANAMIDOMETHYLPHENYL-3-NAPHTHALEN-2-YLMETHYL-1412-TRIOXO-251113-TETRAAZAHEXADECANE-101416-TRICARBOXYLIC Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX17 — -
- Marketing authorisation
- RVG 130642
- MA holder
- ABX ADVANCED BIOCHEMICAL COMPOUNDS BIOMEDIZINISCHE FORSCHUNGSREAGENZIEN GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
- Sponsor organisation
- Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
- Address
- Heinrich-Glaeser-Strasse 10-14
- City
- Radeberg
- Postcode
- 01454
- Country
- Germany
Scientific contact point
- Organisation
- Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
- Contact name
- Director Medicinal Chemistry
Public contact point
- Organisation
- Abx Advanced Biochemical Compounds - Biomedizinische Forschungsreagenzien GmbH
- Contact name
- Director Medicinal Chemistry
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Pharmtrace klinische Entwicklung GmbH ORG-100027256
|
Berlin, Germany | On site monitoring, Code 10, Code 11, Code 12, Code 13, Code 5, Data management, E-data capture |
Locations
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 1 | 2 |
| Germany | Ongoing, recruiting | 248 | 8 |
| Italy | Ongoing, recruiting | 11 | 2 |
| Netherlands | Ongoing, recruiting | 33 | 2 |
| Spain | Ongoing, recruiting | 62 | 3 |
| Rest of world
Japan, United States
|
— | 80 | — |
Investigational sites
Centre Leon Berard
Nuclear Medicine, 28 Rue Laennec, 69008, Lyon
CHRU De Nancy
Nuclear Medicine, Vandoeuvre-Les-Nancy Cedex, 11 Rue Du Morvan, Vandoeuvre Les Nancy Cedex
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Nuclear Medicine, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaet Leipzig
Nuclear Medicine, Liebigstrasse 18, Zentrum-Suedost, Leipzig
Universitaetsklinikum Duesseldorf AöR
Nuclear Medicine, Moorenstrasse 5, Bilk, Duesseldorf
Klinikum rechts der Isar der TU Muenchen AöR
Nuclear Medicine, Ismaninger Strasse 22, Au-Haidhausen, Munich
University Medical Center Hamburg-Eppendorf
Nuclear Medicine, Martinistrasse 52, Eppendorf, Hamburg
St. Antonius-Hospital Gronau GmbH
Nuclear Medicine, Moellenweg 22, 48599, Gronau (Westf.)
Rostock University Medical Center
Nuclear Medicine, Gertrudenplatz 1, Kroepeliner Tor Vorstadt, Rostock
Universitaetsklinikum Muenster AöR
Nuclear Medicine, Gebaeude A1, Albert-Schweitzer-Campus 1, Muenster
IRCCS Ospedale Sacro Cuore Don Calabria
Nuclear Medicine, Via Don Angelo Sempreboni 5, 37024, Negrar
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Nuclear Medicine, Via Piero Maroncelli 40, 47014, Meldola
Stichting Radboud University Medical Center
Nuclear Medicine, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Canisius Wilhelmina Hospital
Urology, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
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 |
|---|---|---|---|---|---|
| Germany | 2024-11-28 | 2024-11-28 | |||
| Italy | 2026-01-08 | 2026-01-08 | |||
| Netherlands | 2025-08-27 | 2025-08-27 | |||
| Spain | 2024-06-05 | 2024-06-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 2 · Art. 52 CTR
Serious breach SB-111295
- Sponsor became aware
- 2025-11-26
- Date of breach
- 2025-04-25
- Submission date
- 2025-12-16
- Member states concerned
- Spain, France, Netherlands, Germany, Italy
- Categories
- Regulation, Protocol
- Areas impacted
- Subject rights, Data reliability or robustness, Regulatory
- Benefit-risk balance changed
- No
- Description
- On 26 November 2025, it was identified that sub-investigators who are not affiliated with the ethics-approved clinical trial site performed trial-specific procedures and obtained informed consent from participants.
Although these external sub-investigators were trained on the study protocol and formally delegated by the Principal Investigator, they were not listed as members of the ethics-approved site and were not included in the ethics committee’s approval of site staff. Under the approved protocol and ethical approval, only personnel affiliated with the approved site are authorized to conduct study procedures.
This situation constitutes a serious breach because:
• Study activities were conducted by individuals not approved by the ethics committee to act as investigators at the site.
• The ethical approval does not cover these external personnel, even if trained and delegated.
• Informed consent obtained by individuals not approved by the ethics committee may not meet regulatory requirements.
• Data generated by personnel outside the approved site framework may be non-compliant.
Impacts include:
• Non-compliance with ICH-GCP and national regulatory requirements.
• Ethical non-compliance due to activities being carried out outside the scope of the approved site.
• Potential invalidation of data and informed consent for impacted subjects. - Sponsor actions
- Immediate actions:
• A temporary recruitment hold was implemented at the site on 03 Dec 2025.
• All study-related activities by the external sub-investigators were stopped immediately.
• The site and PI were notified in writing of the breach and asked to provide clarification.
• All subjects impacted by the involvement of external sub-investigators are being identified.
Corrective actions:
• Conduct a full root-cause analysis with the PI, site staff, CRO and sponsor
• Review all informed consent forms and procedures conducted by the external sub-investigators.
• Determine whether re-consenting of affected subjects is required.
• Assess the reliability and validity of any data collected by the external sub-investigators.
• Collection of external site documents for ethics committee approval
• Site audit
Preventive actions:
• Retraining of the PI and site staff on ethics approval requirements, site boundaries, and permitted delegation.
• Update site oversight procedures to ensure that only individuals approved by the ethics committee can be delegated trial tasks.
• Strengthen monitoring checks related to delegation and staff affiliation.
| Organisation | City | Country | Type |
|---|---|---|---|
| Hospital 9 De Octubre S.A. | Valencia | Spain | Clinical investigator |
Serious breach SB-99725
- Sponsor became aware
- 2025-09-23
- Date of breach
- 2025-07-16
- Submission date
- 2025-09-30
- Member states concerned
- Spain, France, Netherlands, Germany, Italy
- Categories
- Regulation, Protocol
- Areas impacted
- Subject rights
- Benefit-risk balance changed
- No
- Description
- The subject did not receive the assigned study drug as per the study protocol. Instead, the subject was administered a different radiopharmaceutical that is approved by the European Medicines Agency for the same indication as the study drug. The subject is no longer eligible for efficacy assessments within the context of the study and was therefore immediately withdrawn by the investigator.
- Sponsor actions
- Corrective and Preventive Actions (CAPA) and Follow-up Tasks:
1) Site's Immediate Action:
From now on, no other PET/CT scans (non-study related) will be scheduled on the same day as study patients to avoid confusion.
2) CRA Follow-Up:
The Clinical Research Associate called site to clarify incident (26-Sep-2025); urgent monitoring visit scheduled on (08-Oct-2025)
3) Site Staff Re-Training:
The study team at the site received re-training on the inclusion and exclusion criteria to ensure subjects are properly screened and eligible before taking part in the study (via email on 30-Sep-2025); will receive in-person training during next IMV (08-Oct-2025).
4) Review of IMP Administration:
The CRA will review and confirm that the correct study drug was given to all other study participants at the site to make sure no similar mistakes occurred (during next IMV 08-Oct-2025).
| Organisation | City | Country | Type |
|---|---|---|---|
| Hospital 9 De Octubre S.A. | Valencia | Spain | Clinical investigator |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 38 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol EU CT 2023-504026-19-01_redacted | 5.0 |
| Protocol (for publication) | D1_ Protocol EU CT 2023-504026-19-01_tracked_changes_redacted | 5.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_EN | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_ENG | 1.1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_ENG | 1.1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_NL | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults DE_redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults ES_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults ES_tracked_changes_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults IT_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults NL_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults NL_tracked_changes_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_DE site 216_clean_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L2_ Data Processing_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_patient reimbursement_DE_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_patient reimbursement_ES_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC 18F-PSMA-1007 solution for injection 1300MBq | 02/07 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC 18F-PSMA-1007 solution for injection 2000MBq | 03/07 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 1300MBq_ES | 07/04 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 1300MBq_IT | 19/03 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 1300MBq_MASTER | 05/06 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 1300MBq_NL | 15/03 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 2000MBq_ES | 08/04 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 2000MBq_IT | 20/03 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 2000MBq_MASTER | 06/06 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC 18F-PSMA-1007 solution for injection 2000MBq_NL | 16/03 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE EU CT 2023-504026-19-01_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE EU CT 2023-504026-19-01_tracked_changes_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EN EU CT 2023-504026-19-01_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EN EU CT 2023-504026-19-01_tracked_changes_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES EU CT 2023-504026-19-01_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES EU CT 2023-504026-19-01_tracked_changes_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR EU CT 2023-504026-19-01_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR EU CT 2023-504026-19-01_tracked_changes_redacted | 3.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT EU CT 2023-504026-19-01_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT EU CT 2023-504026-19-01_tracked changes_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL EU CT 2023-504026-19-01_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL EU CT 2023-504026-19-01_tracked_changes_redacted | 5.0 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-04 | France | Acceptable 2024-01-10
|
2024-01-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-05 | France | Acceptable 2024-04-12
|
2024-04-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-18 | Acceptable | 2024-05-08 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-05-30 | Acceptable 2024-04-12
|
2024-08-23 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-09-26 | France | Acceptable 2024-11-28
|
2024-11-29 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-06 | Acceptable 2024-11-28
|
2025-02-06 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-14 | France | Acceptable 2025-03-24
|
2025-03-24 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-05-22 | Acceptable 2025-03-24
|
2025-05-22 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-01 | France | Acceptable 2025-08-31
|
2025-09-01 |
| 10 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-09-18 | Acceptable | 2025-10-29 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-12-19 | France | Acceptable 2026-03-18
|
2026-03-19 |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-09 | Acceptable 2026-03-18
|
2026-04-09 |