Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
124
Countries
2
Sites
6
Newly diagnosed prostate cancer
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 11 Dec 2023 → ongoing
- Decision date (initial)
- 2023-10-12
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Newly diagnosed prostate cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Center
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 16 | 2 |
| Spain | Ongoing, recruitment ended | 28 | 4 |
| Rest of world
United States, Australia, Canada, United Kingdom
|
— | 80 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Vakgroep Urologie, Plesmanlaan 121, 1066 CX, Amsterdam
Stichting Radboud University Medical Center
Medical Oncology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Hospital Clinic De Barcelona
Servicio de Urología, Calle Villarroel 170, 08036, Barcelona
Fundacion Instituto Valenciano De Oncologia
Servicio de Oncología, Calle De Gregorio Gea 3, Edificio Consultas Externas 1ª Planta, Valencia
Hospital Universitari Vall D Hebron
Servicio de Oncología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Servicio de Oncología, Bloque D, Avenida De Cordoba S/n, Madrid
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 |
|---|---|---|---|---|---|
| Netherlands | 2023-12-14 | 2026-03-31 | 2024-07-30 | 2026-03-31 | |
| Spain | 2023-12-11 | 2024-01-08 | 2026-03-31 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-20 | Netherlands | Acceptable 2023-10-09
|
2023-10-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-31 | Netherlands | Acceptable | 2023-11-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-23 | Netherlands | Acceptable 2024-03-25
|
2024-03-25 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-26 | Netherlands | Acceptable 2024-07-15
|
2024-07-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-07 | Netherlands | Acceptable 2025-01-21
|
2025-01-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-08-28 | Netherlands | Acceptable 2025-10-15
|
2025-10-17 |
| 7 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-06 | Netherlands | Acceptable 2026-05-08
|
2026-05-13 |