Overview
Sponsor-declared trial summary
Prostate cancer
Evaluate the lesion-specific expression of prostate-specific membrane antigen (PSMA) and fibroblast activation-protein (FAP) in metastatic prostate cancer
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Decision date (initial)
- 2024-02-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511104-16-00
- EudraCT number
- 2022-003788-13
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluate the lesion-specific expression of prostate-specific membrane antigen (PSMA) and fibroblast activation-protein (FAP) in metastatic prostate cancer
Conditions and MedDRA coding
Prostate cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Men with histologically confirmed prostate cancer
- Age 50-85 years at baseline
- WHO performance score 0-2
- At least one distant metastasis detected on CT, MRI, bone scintigraphy (BS) or single-photon emission computed tomography (SPECT) imaging
- All previous treatment lines are allowed
- Patient signs informed consent form after receiving written information
Exclusion criteria 2
- Patient is not able to understand the purpose of the study
- Medical conditions prohibiting whole-body PET/CT imaging
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The proportion of subject with PSMA- and/or FAPI-positive metastases and number of metastases
Secondary endpoints 2
- The proportion of detected metastasis with 18F-FAPI-74 PET/CT compared to the 18F-DCFPyL PET/CT
- The sensitivity, specificity, accuracy, and area under the receiver-operating characteristic curve (AUC) values of 18F-DCFPyL PET/CT and 18F-FAPI-74 PET/CT in detecting metastatic subjects
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10896779 · Product
- Active substance
- [AL18FFFAPI-74
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 250 MBq megabecquerel(s)
- Max total dose
- 250 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- VARSINAIS-SUOMEN HYVINVOINTIALUE
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
18F-DCFPyL CURIUM, 1000 MBq/mL solution for injection
PRD10312835 · Product
- Active substance
- Piflufolastat (18F)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 333 MBq megabecquerel(s)
- Max total dose
- 333 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX16 — -
- Marketing authorisation
- NA
- MA holder
- CURIUM PET FRANCE
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- PET-keskus
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- PET-keskus
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-10 | Finland | Acceptable 2024-02-26
|
2024-02-28 |