PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

TACTIC-P is a single-center, prospective, single-arm study enrolling 12 men with biopsy-proven prostate cancer and PSMA-avid pelvic lymph nodes who are planned for robot-assisted radical prostatectomy with extended pelvic lymph-node dissection. On the day of surgery, participants receive gallium-68 PSMA-11, undergo PET/CT imaging, and then have PSMA-radioguided surgery using a gamma probe. Resected tumor tissue, metastatic lymph nodes, and matched blood samples undergo comprehensive molecular profiling, including single-cell and T-cell receptor sequencing, to explore tissue-resident bystander T cells and their potential relevance for personalized immunotherapy. The study also assesses the feasibility of PSMA-radioguided surgery to detect positive lymph nodes and monitors perioperative safety for 12 weeks.

Why it matters

Who can join: the full rules

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.

Where it's running

• ASST Grande Ospedale Metropolitano Niguarda
  Milan, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Elio Mazzone, MD
• Email: elio.mazzone@ospedaleniguarda.it
• Phone: +393398431192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.