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

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

NCT ID: NCT05596851

Condition: Prostate Cancer
Positron Emission Tomography
PSMA

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
PSMA
Radio-Guided Surgery
Radio Guided Surgery
Lymph Node Dissection
Prostate Cancer
PET
Positron Emission Tomography

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

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).

Criteria for eligibility:

Study pop:
Biopsy proven high-risk prostate cancer patients, who performed PSMA PET/CT per clinical routine practice will be considered suitable for enrollment in case of pelvic nodal involvement detected at PSMA PET/CT. Patients affected by metastatic prostate cancer (any M) will be considered not eligible.

Sampling method: Probability Sample
Criteria:
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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: IEO European Institute of Oncology

Address:
City: Milan
Zip: 20141
Country: Italy

Status: Recruiting

Contact:
Last name: Francesco Ceci, MD PhD

Contact backup:
Last name: Gennaro Musi, MD

Start date: March 21, 2022

Completion date: December 1, 2023

Lead sponsor:
Agency: European Institute of Oncology
Agency class: Other

Source: European Institute of Oncology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05596851
https://www.ieo.it/it/CHI-SIAMO/Come-siamo-organizzati/Le-divisioni/Divisione-di-Medicina-Nucleare-MNUDV/
https://www.ieo.it/it/CHI-SIAMO/Come-siamo-organizzati/Le-divisioni/Divisione-di-Urologia-URODV/