Overview
Sponsor-declared trial summary
Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data
The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in this setting.
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] - Male Urogenital Diseases [C12]
- Trial duration
- 5 May 2021 → 10 Dec 2024
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514583-12-00
- EudraCT number
- 2020-003183-68
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety
The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in
this setting.
Conditions and MedDRA coding
Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male patients
- Age between 18 and 80 years
- Biopsy proven PCa with a LNI risk >5% according to the Briganti nomogram
- Planned to receive a RARP with an ePLND
- Able to understand and willing to sign a written informed consent document
Exclusion criteria 14
- Receipt of neoadjuvant therapies
- Inability to complete the imaging examinations according to the prospective protocol
- Evidence of metastatic disease at conventional imaging before surgery
- Evidence of clinical lymphadenopathies at conventional imaging before surgery
- Life expectancy of less than 12 months
- Previous chemotherapy
- Previous brachytherapy or external beam radiotherapy
- Unstable cardiovascular disease
- Congestive Heart Failure (CHF)
- Clinically significant hepatobiliary or renal disease
- History of significant CNS injuries within 6 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I&S and 68Ga-PSMA)
- Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (namely, histopathological evaluation of the lymph nodes done by a dedicated high-volume uropathologists, the results are typically available 10 days after surgery).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11572813 · Product
- Active substance
- 2-5-3-6-5S-5-CARBOXY-5-1S-13-DICARBOXYPROPYLCARBAMOYLAMINOPENTYLAMINO-6-OXOHEXYLAMINO-3-OXOPROPYL-2-OXIDOPHENYLMETHYL-2-5-2-CARBOXYETHYL-2-OXIDOPHENYLMETHYL-CARBOXYLATOMETHYLAMINOETHYLAMINOACETATEGALLIUM-683) Hydron
- Substance synonyms
- 68GA-PSMA HBED-CC
- Pharmaceutical form
- INJECTION/INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 160 MBq megabecquerel(s)
- Max total dose
- 160 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- OSPEDALE SAN RAFFAELE
- Paediatric formulation
- No
- Orphan designation
- No
PRD11624653 · Product
- Active substance
- [99MTCPSMA I&S
- Pharmaceutical form
- INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 850 MBq megabecquerel(s)
- Max total dose
- 850 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- OSPEDALE SAN RAFFAELE
- 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
- Giorgio Gandaglia
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Giorgio Gandaglia
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 100 | 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 | 2021-05-05 | 2024-12-10 | 2021-05-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results SUM-79743
|
2025-04-21T00:53:18 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| lay person summary of results | 2025-04-20T21:51:35 | Submitted | Laypersons Summary of Results |
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | CTC 051Lita_1 | 1 |
| Protocol (for publication) | D1_Protocol_2024-514583-12-00_Redacted | 4.0 |
| Recruitment arrangements (for publication) | Blank document_ not required under directive | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_adults | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_Privacy | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_Privacy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_Redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_68Ga-PSMA | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_99mTc-PSMA | 2 |
| Summary of results (for publication) | Summary of results | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-02 | Italy | Acceptable 2024-10-29
|
2024-11-11 |