Skip to content

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516319-25-00
Acronym
29BRC20.0203
Enrollment
159
Registered
2024-11-26
Start date
Unknown
Completion date
2025-12-15
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

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.

Detailed description

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

Interventions

Sponsors

Centre Hospitalier Regional Et Universitaire De Brest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026