Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
205
Countries
1
Sites
4
Metastatic Prostate Cancer
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jun 2025 → ongoing
- Decision date (initial)
- 2025-03-10
- 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
Metastatic Prostate Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10036909 | Prostate cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 15 | 4 |
| Rest of world
Australia, Korea, Republic of, United States
|
— | 190 | — |
Investigational sites
Hospital Universitari Vall D Hebron
Oncology Service, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Oncology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Oncology Service, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Hm Sanchinarro
Oncology Service, Calle Ona 10, 28050, 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 |
|---|---|---|---|---|---|
| Spain | 2025-06-30 | 2025-06-30 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-26 | Spain | Acceptable 2025-03-06
|
2025-03-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-14 | Spain | Acceptable 2025-04-30
|
2025-05-20 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-04 | Spain | Acceptable 2025-10-15
|
2025-10-20 |