Overview
Sponsor-declared trial summary
High-risk prostate cancer
To assess if neoadjuvant therapy with pembrolizumab is associated with a reduction in the rate of lymph node invasion in prostate cancer patients at high risk of recurrence after surgery.
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
- completed 22 Apr 2026
- Decision date (initial)
- 2024-10-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514580-26-00
- EudraCT number
- 2019-004782-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess if neoadjuvant therapy with pembrolizumab is associated with a reduction in the rate of lymph node invasion in prostate cancer patients at high risk of recurrence after surgery.
Conditions and MedDRA coding
High-risk prostate cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate cancer
- PCa detected at prostate biopsy with a risk of lymph node invasion higher than 5% according to the Briganti nomogram
- The participant should be fit and planned for RP and ePLND
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
- Did not start novel therapies within the 4 weeks before the beginning of the study
- Willingness to use contraception during study treatment
Exclusion criteria 13
- Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
- Unable to complete the diagnostic investigations required per protocol
- Evidence of metastases at preoperative imaging
- Evidence of lymph node invasion before surgery
- Life expectancy shorter than 12 months
- History of chemotherapy
- History of brachytherapy or EBRT
- Cardiovascular diseases not controlled by medical therapy
- Hearth failure
- Clinically relevant hepatic or renal diseases
- Onset of cerebral diseases within 6 months before the study beginning
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Severe hypersensitivity (Grade 3) to pembrolizumab and/or any of its excipients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- A reduction of 50% in the rate of node positive patients compared to what currently reported in the literature represents the main endpoint of the study (rate of pN0 of 85 vs. 70%)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323786 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
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
- Francesco Montorsi
Public contact point
- Organisation
- Ospedale San Raffaele S.r.l.
- Contact name
- Francesco Montorsi
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ended | 59 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514580-26-00_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_Bio_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_adults_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | Blank document statement unpublished | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_IB_68Ga-PSMA | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Italy | Acceptable 2024-10-03
|
2024-10-08 |