Overview
Sponsor-declared trial summary
Patients with prostate cancer with: -suspected metastasis who are candidates for initial definitive therapy -suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL) -metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands
Key facts
- Sponsor
- Philogen S.p.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 19 Mar 2025 → 3 Oct 2025
- Decision date (initial)
- 2024-11-27
- 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
Patients with prostate cancer with: -suspected metastasis who are candidates for initial definitive therapy -suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL) -metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Philogen S.p.A.
- Sponsor organisation
- Philogen S.p.A.
- Address
- Piazza La Lizza 7
- City
- Siena
- Postcode
- 53100
- Country
- Italy
Scientific contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Public contact point
- Organisation
- Philogen S.p.A.
- Contact name
- Jacqueline Mock
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 20 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Italy | 2025-03-19 | 2025-10-03 | 2025-04-08 | 2025-09-30 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | Italy | Acceptable 2024-11-25
|
2024-11-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-18 | Italy | Acceptable 2024-11-25
|
2025-11-18 |