Status:
COMPLETED
Imaging Guided Surgery to Improve the Detection of Lymph Node Metastases in Prostate Cancer Patients
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief Summary
The project aims at assessing the role of radio-guided surgery in the detection of lymph node invasion (LNI) in prostate cancer (PCa) patients undergoing radical prostatectomy (RP) by using an intraop...
Detailed Description
Potential participants will be identified, screened and recruited by the Urologists working at the Department of Urology, IRCCS San Raffaele, Milan, Italy. A total of 100 patients affected by PCa with...
Eligibility Criteria
Inclusion
- Male patients
- Age between 18 and 80 years
- Biopsy proven PCa with a LNI risk \>5% according to the Briganti nomogram
- Planned to receive a RARP with an ePLND
- Able to understand and willing to sign a written informed consent document
Exclusion
- Receipt of neoadjuvant therapies
- Inability to complete the imaging examinations according to the prospective protocol
- Evidence of metastatic disease at conventional imaging before surgery
- Evidence of clinical lymphadenopathies at conventional imaging before surgery
- Life expectancy of less than 12 months
- Previous chemotherapy
- Previous brachytherapy or external beam radiotherapy
- Unstable cardiovascular disease
- Congestive Heart Failure (CHF)
- Clinically significant hepatobiliary or renal disease
- History of significant CNS injuries within 6 months
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- Medical history of allergic disease or reactions likely to be exacerbated by the IMPs used in this study or by any of the components of the radiotracers (99mTc-PSMA-I\&S and 68Ga-PSMA)
- Patients who received an experimental drug in the context of clinical trials within 30 days from the administration of the radiotracers in the current investigation or within 5 half-lives of the experimental drug itself
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04832958
Start Date
May 15 2021
End Date
November 15 2024
Last Update
March 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale San Raffaele
Milan, MI, Italy, 20132