Prostate Cancer
Conditions
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
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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