The implementation of imaging guidance in surgery for patients with prostate cancer who are candidate to undergo robot-assisted prostatectomy and lymph node removal
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ospedale San Raffaele S.r.l.
- Trial code
- EU 2024-514583-12-00
- Record updated
- 2024. november 11.
- Original description
The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in this setting.Read full original descriptionShow less
The Role of Imaging Guided Surgery to Improve the Detection of Lymph Node metastases in Prostate Cancer Patients Treated with Radical Prostatectomy and Extended Pelvic Lymph Node Dissection
The objective of the study is to improve clinicians’ ability to identify LNI in PCa patients undergoing RARP with an ePLND and to assess the role of 99mTc-PSMA-I&S in this setting.
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; 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; Evidence of clinical lymphadenopathies at conventional imaging before surgery; Previous chemotherapy; Previous brachytherapy or external beam radiotherapy; 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); Evidence of metastatic disease at conventional imaging before surgery; Unstable cardiovascular disease; Congestive Heart Failure (CHF); Inability to complete the imaging examinations according to the prospective protocol; Life expectancy of less than 12 months.