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PSMA-Guided Surgery and Tissue-Resident T-Cell Profiling in Node-Positive Prostate Cancer
Sponsor: Niguarda Hospital
Summary
TACTIC-P is a single-center, prospective, single-arm study in 12 men with biopsy-proven prostate cancer and pelvic lymph-node uptake on preoperative PSMA PET, without bone or visceral metastases, who are scheduled for robot-assisted radical prostatectomy and extended pelvic lymph-node dissection. On the day of surgery, participants receive intravenous gallium-68 PSMA-11 followed by PET/CT and PSMA-radioguided surgery using a drop-in gamma probe. Resected prostate tumor, metastatic lymph-node tissue, and matched blood samples are used for high-dimensional immune profiling. The main goal is to determine whether functional pathogen-specific bystander tissue-resident T cells can be identified and quantitatively characterized in the primary tumor and/or metastatic lymph nodes. The study also evaluates immune features relevant to future personalized immunotherapy, the ability of PSMA-radioguided surgery to detect pathologically positive lymph nodes, and perioperative safety through 12 weeks after surgery.
Official title: Targeting Tissue-Resident T Cells for Personalized Immunotherapy and Recurrence Prevention in Patients With Node-Positive Prostate Cancer Undergoing PSMA-Guided Surgery
Key Details
Gender
MALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-10-01
Completion Date
2028-08-31
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection
Retzius-sparing robot-assisted radical prostatectomy with anatomically defined ePLND. Radioactive lesions identified intraoperatively are excised and assessed ex vivo; prostate fossa and additional nodal stations are also evaluated with the probe.
Locations (1)
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy