PSMA-guided surgery and immune cell study in prostate cancer that has reached lymph nodes
Studies immune cells in tumor tissue during PSMA-guided surgery in 12 men with prostate cancer.
Plain-language title generated from the registry record
Registry title: PSMA-Guided Surgery and Tissue-Resident T-Cell Profiling in Node-Positive Prostate Cancer
Key facts
- Where
- Milan, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07879820, who can take part
Where in Italy
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Niguarda Hospital
- Trial code
- NCT07879820
- Record updated
- 19 October 2026
- Original 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.Read full original descriptionShow less
Targeting Tissue-Resident T Cells for Personalized Immunotherapy and Recurrence Prevention in Patients With Node-Positive Prostate Cancer Undergoing PSMA-Guided Surgery
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.
Inclusion: 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: Neoadjuvant hormonal therapy before surgery; Previous chemotherapy; Previous brachytherapy or external-beam radiotherapy; Experimental drug within 30 days before radiotracer administration or within 5 half-lives of that experimental drug; Bone or visceral metastatic disease (M1b-c) on preoperative imaging; 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); Inability to complete imaging examinations according to the protocol; Life expectancy <12 months.