NCT07879820Recruiting
PSMA-Guided Surgery and Tissue-Resident T-Cell Profiling in Node-Positive Prostate Cancer
Targeting Tissue-Resident T Cells for Personalized Immunotherapy and Recurrence Prevention in Patients With Node-Positive Prostate Cancer Undergoing PSMA-Guided Surgery
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 10 Oct 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Niguarda Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07879820
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 1 Oct 2026 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- Inability to complete imaging examinations according to the protocol.
- Life expectancy \<12 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.