Prostate cancer
Conditions
Interventions
PSMA-targeted fluorescence navigation–assisted robot-assisted radical prostatectomy (Single-arm):Intravenous injection of ICG-18F-PSMA fluorescent probe at 1 µg/kg 24 hours before surgery, followed by
vital signs and potential adverse reactions will be dynamically monitored after injection.
Intraoperative PSMA-targeted fluorescence image-guided navigation using the da Vinci Firefly near-infrared im
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Male
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with prostate adenocarcinoma via transrectal prostate biopsy; 2. Scheduled to undergo robot-assisted radical prostatectomy. 3. Preoperative assessment indicates suspected tumour capsular invasion.
Exclusion criteria
Exclusion criteria: 1.Biopsy pathology indicates a special histologic subtype; 2.Acute urinary tract infection not adequately controlled; 3.History of allergic reactions to PSMA imaging agents or fluorescent contrast agents; 4.Prior radiotherapy or surgery involving the lower urinary tract or pelvis; 5.Current hepatic or renal dysfunction (laboratory values >2× the upper limit of normal); 6.Major comorbidities (e.g., autoimmune disease, angina, heart failure, hematologic disorders, severe respiratory or gastrointestinal diseases), or deemed unable to tolerate surgery by multidisciplinary evaluation; 7.Any other condition considered unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive surgical margin rate;Urinary continence recovery rate at 1 month postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection rate of extraprostatic extension (EPE);Intraoperative fluorescence detection rate versus PET-MR and pathology detection rates;Time to biochemical recurrence after surgery;Neurovascular bundle (NVB) preservation status and erectile function preservation rate;Rate of surgical plan modification (change in surgical approach); | — |
Countries
China
Contacts
Public ContactBangmin Han
Shanghai General Hospital
Outcome results
None listed