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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596851
• Other study ID #: IEO 1703
• Status: Recruiting
• Start date: March 21, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2022
• Source: European Institute of Oncology
• Contact: Francesco Ceci, MD
• Phone: +39 02-57489 315
• Email: francesco.ceci[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Positron Emission Tomography
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Italy	IEO European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity, specificity and positive predictive value in a per-region analysis		March 2022 - March 2023
Secondary	Comparison of ß-probe intra-operatory measurements with ex-vivo ones.		March 2022 - March 2023
Secondary	Comparison of ß-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters	SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters	March 2022 - March 2023
Secondary	Comparison of ß-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

External Links

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