Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.

Study Overview
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Brief Summary
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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
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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).

Official Title
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PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.

Conditions
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PSMA, Prostate Cancer, Positron Emission Tomography

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity and positive predictive value in a per-region analysis |  | March 2022 - March 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters | March 2022 - March 2023 | 
| Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC). | IHC will be evaluated by PSMA staining on the surgical specimens. | May 2022 - December 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA, Radio-Guided Surgery, Radio Guided Surgery, Lymph Node Dissection, Prostate Cancer, PET, Positron Emission Tomography