Positron Emission Tomography, Prostate Cancer, PSMA
Conditions
Keywords
PSMA, Radio-Guided Surgery, Radio Guided Surgery, Lymph Node Dissection, Prostate Cancer, PET, Positron Emission Tomography
Brief summary
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
Detailed description
Study Phase: Phase II Primary Objective: To evaluate the diagnostic accuracy of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection. The histopathological analysis of the surgical specimens will be considered the standard of reference and diagnostic accuracy will be evaluated in terms of sensitivity and specificity. Secondary Objectives: * the identification of the most appropriate tumor-to-background ratio (TBR) able to correctly locate the signal emitted by PSMA-positive lymph nodes compared with the signal derived by the background rumor. * safety and toxicity analysis regarding the intraoperative application of the β-probe. * the comparison between the signal detected by the β-probe and 68Ga-PSMA-11 PET/CT images. * the correlation of the signal detected by the β-probe with the PSMA expression (PSMA staining) in lymph node metastases assessed by immuno-histochemical analysis on the surgical specimens Drug Dosage, Formulation, Administration: Intravenous administration of 1.1 MBq/Kg of 68Ga-PSMA-11. Primary Endpoint: Primary: sensitivity and specificity in a per-region analysis. Secondary Endpoints: * comparison of β-probe intra-operatory measurements with ex-vivo ones. * comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters (SUVmax and PSMA-TV). * comparison of β-probe measurements and PSMA expression assessed by IHC (PSMA staining).
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven prostate cancer * High-risk prostate cancer (T\>T2c and/or PSA\>20 and/or ISUP\>3) * Patients suitable for radical prostatectomy + pelvic lymph node dissection * 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery * PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT * Age \>18 years old * Willing to sign informed consent
Exclusion criteria
* Patient unfit for surgery * M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation * Unable to tolerate PET scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity and positive predictive value in a per-region analysis | March 2022 - March 2023 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of β-probe intra-operatory measurements with ex-vivo ones. | March 2022 - March 2023 | — |
| Comparison of β-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters | March 2022 - March 2023 | SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters |
| Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC). | May 2022 - December 2023 | IHC will be evaluated by PSMA staining on the surgical specimens. |
Countries
Italy
Contacts
Primary ContactFrancesco Ceci, MD
Outcome results
None listed