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

Phase 2

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: 2024-516319-25-00
• Lead Sponsor: Centre Hospitalier Regional Et Universitaire De Brest

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-26
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 159

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.		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 Outcome Measures

Name	Time	Method
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.		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)		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).		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		Adverses events recorded during the assessment

Trial Locations

Locations (1)

Centre Hospitalier Regional Et Universitaire De Brest; 🇫🇷 Brest, France

Centre Hospitalier Regional Et Universitaire De Brest

🇫🇷Brest, France

Philippe ROBIN

Site contact

0298223327

philippe.robin@chu-brest.fr