Localization of lymph nodes by fluorescent agents in robotic prostate cancer surgery

Clinical research on analysis of pelvic lymph flow in prostate cancer, and establishment of sentinel lymph node search method for pelvic lymph node dissection navigation by ICG fluorescence method using a surgical support robot (Da Vinci Xi): a phase II exploratory clinical study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240188

Enrollment

Registered

2024-06-27

Start date

2024-10-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Prostate

Interventions

ICG injection during robotic surgery.

D065287

ICG

Robotsurgery

Da Vinci Xi

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1)Patients with prostate cancer of stage T1-3N0-1M0 who need radical prostatectomy using da Vinci Xi. 2) Age from 35 to 85 years old. 3) PS0-1 (ECOG performance status score) 4) The examination results within three months indicate that the patient can undergo general anesthesia surgery. 5) Obtain written informed consent.

Exclusion criteria

Exclusion criteria: 1) case of iodine hypersensitivity or a history of drug allergy to a drug to be used (ICG etc.) 2) cases suspected of disseminated disease outside the pelvis 3) cases deemed inappropriate by research responsibility or research sharing physician

Design outcomes

Primary

Measure	Time frame
The percentage of pelvic lymphatic pathway (pathway A/B/C etc.) (%)	—

Secondary

Measure	Time frame
1) site-specific lymph node ICG staining 2) evaluation of the accuracy of identification of metastatic lymph nodes by ICG Sensitivity of metastatic lymph nodes The specificity of metastatic lymph nodes False-positive rate of metastatic lymph nodes False-negative rate of metastatic lymph nodes 3) safety evaluation items Number of adverse events (specific adverse events, number of responses and proportion)	—

Measure

Time frame

1) site-specific lymph node ICG staining 2) evaluation of the accuracy of identification of metastatic lymph nodes by ICG Sensitivity of metastatic lymph nodes The specificity of metastatic lymph nodes False-positive rate of metastatic lymph nodes False-negative rate of metastatic lymph nodes 3) safety evaluation items Number of adverse events (specific adverse events, number of responses and proportion)

—

Contacts

Public ContactShinichi Sakamoto

Chiba University Hospital

rbatbat1@chiba-u.jp+81-43-226-2134

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026