Overview
Sponsor-declared trial summary
Prostate Cancer
To determine the diagnostic performance of Positron Emission Tomography with Prostate Specific Membrane Antigen Ligands (PET-PSMA) for the detection of lymph node metastases in intermediate or high-risk prostatic neoplasia for which radical treatment by prostatectomy is selected by the multidisciplinary consultation me…
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- completed 15 Dec 2025
- Decision date (initial)
- 2024-11-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516319-25-00
- EudraCT number
- 2020-003323-42
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To determine the diagnostic performance of Positron Emission Tomography with Prostate Specific Membrane Antigen Ligands (PET-PSMA) for the detection of lymph node metastases in intermediate or high-risk prostatic neoplasia for which radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting
Secondary objectives 4
- To assess the clinical impact of PET-PSMA on the surgical strategy for lymph node dissection, and in particular the extension of lymph node dissection to a suspected resectable area.
- Comparing MRI and PET-PSMA data with anatomopathological data for the prostate
- Determine the positive predictive value of PET-PSMA for detecting distant visceral or bone metastases in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting.
- Confirmation of data on the perfect tolerance of 68Ga-HBED-CC-PSMA and 68Ga-PSMA-11
Conditions and MedDRA coding
Prostate Cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients over 18 years of age
- Histologically confirmed prostatic neoplasia
- Intermediate-risk neoplasia (PSA between 10 and 20 ng/mL and/or TR showing T2b and/or ISUP 2 or 3, AND with risk of lymph node extension > 5% according to the Briganti nomogram) or high-risk neoplasia (PSA ≥ 20 ng/mL and/or TR ≥ T2c and/or ISUP 4 or 5) according to the d'Amico classification
- Radical treatment by total prostatectomy selected by the multidisciplinary consultation meeting
- Patient affiliated to or benefiting from a health insurance scheme.
Exclusion criteria 6
- Refusal or inability to take part in the study
- Prostatic neoplasia with low risk of extension according to the Amico classification, or intermediate risk but with a risk of lymph node extension <5% according to the Briganti nomogram
- Curative treatment other than surgery selected
- Life expectancy < 12 months
- Karnofsky score < 70 or ECOG score > 2
- Patient under guardianship or trusteeship
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate the sensitivity, specificity and likelihood ratios of PET-PSMA for the detection of lymph node metastases in intermediate- or high-risk prostatic neoplasia in patients whose radical treatment by prostatectomy is selected by the multidisciplinary consultation meeting, by reference to the gold standard (reference test) obtained from histological data and/or imaging follow-up.
Secondary endpoints 4
- Modification of the surgical strategy for lymph node dissection on the basis of the PET-PSMA examination, compared with the strategy that would have been dictated by conventional imaging alone.
- Existence of a pathological focus according to each of the 3 examinations (PET-PSMA, MRI and anatomopathology = gold standard) for each of the 6 following locations: base, middle, prostatic apex (right and left)
- Positive predictive value of PET-PSMA in the detection of distant visceral or bone metastases, taking as the gold standard the diagnosis made by a review committee in the light of the patient's follow-up and the results available in current practice (clinical data, anatomopathology, repeated PSA tests and imaging).
- Adverses events recorded during the assessment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Locametz 25 micrograms kit for radiopharmaceutical preparation
PRD10117083 · Product
- Active substance
- Gozetotide
- Substance synonyms
- AAA517, OH-Glu-CO-Lys(Ahx-CC-HBED)-OH
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 259 MBq megabecquerel(s)
- Max total dose
- 259 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX14 — -
- Marketing authorisation
- EU/1/22/1692/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11635896 · 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
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 5 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 5 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CENTRE HOSPITALIER REGIONAL ET UNIVERSITAIRE DE BREST
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Pr Philippe ROBIN
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Pr Philippe ROBIN
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 159 | 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 2020-003323-42 | 5.0 |
| Protocol (for publication) | D1_Protocol Annex2 2024-516319-25-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recrutement arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 5.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Locametz | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2020-003323-42 | 5.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-03 | France | Acceptable 2024-11-26
|
2024-11-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-11 | France | Acceptable 2025-04-15
|
2025-04-30 |