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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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
Investigators
Pr Philippe ROBIN
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- 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