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
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
15 participants
OBSERVATIONAL
2022-03-21
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients
NCT04832958
Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
NCT06866041
Ga-68-PSMA-11 in High-risk Prostate Cancer
NCT03362359
Radio Guided Lymph Node Dissection in Oligometastatic Prostate Cancer Patients
NCT04300673
Ex-vivo Investigation of Beta Probe for Prostate Cancer Resection and Evaluation of PSMA-PET for Diagnosis of Intraprostatic Lesions
NCT03213951
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Institute of Oncology
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IEO European Institute of Oncology
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Francesco Ceci, MD PhD
Role: primary
Gennaro Musi, MD
Role: backup
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IEO 1703
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.