Radio-guided Surgery With DROP-IN Beta Probe for 68Ga-PSMA, in High-risk Prostate Cancer Patients Eligible for Robotic-assisted Radical Prostatectomy.
PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2022
CompletedFirst Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 27, 2022
October 1, 2022
1.4 years
October 24, 2022
October 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity, specificity and positive predictive value in a per-region analysis
March 2022 - March 2023
Secondary Outcomes (3)
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
Comparison of β-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC).
May 2022 - December 2023
Eligibility Criteria
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.
You may qualify if:
- 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
- Ga-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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IEO European Institute of Oncology
Milan, 20141, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
October 27, 2022
Study Start
March 21, 2022
Primary Completion
September 1, 2023
Study Completion
December 1, 2023
Last Updated
October 27, 2022
Record last verified: 2022-10