2024-516319-25-00CompletedPhase 2
Diagnostic Performance of Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Pre-operative Lymph Node Assessment in Intermediate and High-risk Nonmetastasic Prostate Cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 159 (actual)
- First submitted
- 3 Oct 2024
- Start date
- 20 May 2021
- Lead sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Diseases
- Prostate cancer
- EU CT number
- 2024-516319-25-00
- EudraCT number
- 2020-003323-42
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 159
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Curative treatment other than surgery selected
Other
- 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
- Life expectancy < 12 months
- Karnofsky score < 70 or ECOG score > 2
- Patient under guardianship or trusteeship
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Régional et Universitaire de Brest | Brest | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.