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PSMA-Guided Surgery and Tissue-Resident T-Cell Profiling in Node-Positive Prostate Cancer

Sponsor: Niguarda Hospital • ClinicalTrials.gov ID: NCT07879820

Registry updated: 2026-10-19

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Description

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.

Interventions

PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection (Procedure)
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.

Eligibility criteria

Inclusion Criteria: * Male participants. * Age 18 to 85 years. * Biopsy-proven prostate cancer with positive lymph nodes on staging PSMA PET (miN+). * Planned robot-assisted radical prostatectomy with extended pelvic lymph-node dissection. * Able to understand and willing to sign written informed consent. Exclusion Criteria: * Neoadjuvant hormonal therapy before surgery. * Inability to complete imaging examinations according to the protocol. * Bone or visceral metastatic disease (M1b-c) on preoperative imaging. * Life expectancy \<12 months. * Previous chemotherapy. * Previous brachytherapy or external-beam radiotherapy. * Congestive heart failure. * Any other significant disease/disorder that, in the investigator's opinion, may increase risk, influence study results, or impair participation. * History of allergic disease/reactions likely to be exacerbated by study IMPs or radiotracer components (68Ga-PSMA). * Experimental drug within 30 days before radiotracer administration or within 5 half-lives of that experimental drug.

Conditions

Prostate Cancer

Locations

ASST Grande Ospedale Metropolitano Niguarda — Milan, Lombardy, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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