Overview
Sponsor-declared trial summary
Patients with clinical suspicion of clinically relevant prostate cancer
To determine the diagnostic accuracy of 18F-PSMA PET/MRI for the diagnosis of clinically relevant prostate cancer
Key facts
- Sponsor
- Ospedale San Raffaele S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 4 Dec 2023 → ongoing
- Decision date (initial)
- 2024-10-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512859-21-00
- EudraCT number
- 2022-003905-31
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To determine the diagnostic accuracy of 18F-PSMA PET/MRI for the diagnosis of
clinically relevant prostate cancer
Conditions and MedDRA coding
Patients with clinical suspicion of clinically relevant prostate cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients 18 years of age or older, identified as suspects for clinically significant prostate cancer
- Ability to undergo all protocol scrutiny
- Ability to provide informed consent
Exclusion criteria 3
- Previous diagnosis of prostate cancer
- Contraindications to perform the MRI examination (e.g. claustrophobia, pacemaker, estimated GFR less than or equal to 50mls/min)
- Contraindications to perform the prostate biopsy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Diagnostic accuracy measured by sensitivity, specificity, and positive and negative predictive values
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11572322 · 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
- INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 450 MBq megabecquerel(s)
- Max total dose
- 450 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- OSPEDALE SAN RAFFAELE S.R.L.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ospedale San Raffaele S.r.l.
- Sponsor organisation
- Ospedale San Raffaele S.r.l.
- Address
- Via Olgettina 60
- City
- Milan
- Postcode
- 20132
- Country
- Italy
Scientific contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Maria Picchio
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Maria Picchio
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 167 | 1 |
| 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 | 2023-12-04 | 2023-12-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512859-21-00 | 5.0 |
| Protocol (for publication) | D1_Protocol_2024-512859-21-00_Redacted | 4.0 |
| Recruitment arrangements (for publication) | Blank document_ not required under directive | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS_adults | 1 |
| Subject information and informed consent form (for publication) | L2 _Patient_card_CL_Redatto | 5.0 |
| Subject information and informed consent form (for publication) | L2_ICF Privacy statement_tc | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_18FPSMA | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsisIT 2024-512859-21-00_clean_Redacted | 5.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Italy | Acceptable 2024-10-09
|
2024-10-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | Italy | Acceptable with conditions 2025-06-25
|
2025-06-25 |