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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514583-12-00

Enrollment

100

Registered

2024-11-11

Start date

2021-05-05

Completion date

2024-12-10

Last updated

2024-11-11

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

Conditions

Patients with prostate cancer (PCa) who are candidate to undergo surgical treatment with robot-assisted radical prostatectomy with a risk of lymph nodal invasion > 5% according to preoperative data

Brief summary

Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (namely, histopathological evaluation of the lymph nodes done by a dedicated high-volume uropathologists, the results are typically available 10 days after surgery).

Interventions

DRUG[68GA]PSMA-HBED-CC

DRUG[99mTc]PSMA I&S

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of LNI observed at final pathology after 99mTc-PSMA-RGS (namely, histopathological evaluation of the lymph nodes done by a dedicated high-volume uropathologists, the results are typically available 10 days after surgery).	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026