An interventional study of PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection in Prostate Cancer, sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Niguarda Hospital · Not applicable, Interventional, and Basic science
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.
This exploratory mechanistic study investigates tissue-resident bystander T cells in node-positive prostate cancer and the feasibility of using their molecular and functional features to inform personalized immunotherapeutic strategies. All participants undergo the same study pathway. On Day 0, gallium-68 PSMA-11 is administered intravenously (approximately 1.8-2.8 MBq/kg; standard activity approximately 160 MBq). PET/CT is performed approximately 60 minutes after tracer administration. Robot-assisted PSMA-radioguided surgery is then performed 4-8 hours after injection using a drop-in gamma probe. A positive intraoperative finding is defined as a count rate at least twice the background reference. PSMA-positive lesions are excised, followed by anatomically defined extended pelvic lymph-node dissection and Retzius-sparing robot-assisted radical prostatectomy.
Fresh primary tumor, metastatic lymph-node tissue, FFPE tissue, and matched peripheral blood are collected. The first six participants are used primarily to optimize tissue acquisition and molecular workflows. The subsequent six participants expand the patient-derived tumor fragment platform and ex vivo immunological testing. Molecular analyses include scRNA-seq, scCITE-seq, scTCR-seq, bulk TCR sequencing, functional stimulation with common viral peptide pools, cytokine/chemokine assays, and spatial profiling. Functional bystander tissue-resident T cells are defined using integrated evidence of tissue detection, a resident/non-naive phenotype, ex vivo activation or proliferation after pathogen-derived peptide stimulation, and TCR clonotype identification.
Participants are followed at Day 28 and Day 84 for laboratory tests, adverse events, perioperative outcomes, pathology, and postoperative data. The study is hypothesis-generating and is not powered for confirmatory clinical efficacy testing.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 12 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
All enrolled participants receive 68Ga-PSMA-11 on the day of surgery, undergo PET/CT, PSMA-radioguided surgery with a drop-in gamma probe, extended pelvic lymph-node dissection and Retzius-sparing robot-assisted radical prostatectomy. Resected tumor/lymph-node tissue and matched blood undergo prespecified molecular, spatial, and ex vivo immune analyses
Procedure: 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.
Proportion of Evaluable Participants With Successfully Identified and Quantitatively Characterized Functional Pathogen-Specific Bystander Tissue-Resident T Cells
Number and percentage of evaluable participants in whom functional pathogen-specific bystander tissue-resident T-cell populations/clonotypes are identified in primary prostate tumor and/or matched metastatic lymph-node tissue. Prespecified criteria include: (1) detection by integrated scRNA-seq, scCITE-seq and scTCR-seq; (2) tissue-resident/non-naive phenotype with predefined residency/activation markers such as CD69, 4-1BB/CD137, CD103 and/or CD49a; (3) ex vivo activation and/or proliferation after stimulation with common viral peptide pools (e.g., CMV, EBV, influenza) versus unstimulated controls; and (4) TCR clonotype identification enabling integration with single-cell/spatial datasets.
Time frame: Surgical tissue collected on Day 0; endpoint determined after completion of prespecified molecular and functional analyses during the study period.
Pathology-Positive Lymph Nodes Detected Only by 68Ga-PSMA Radioguided Surgery
Rate of lymph nodes that are positive at final pathology within the dissection template and were detected only by 68Ga-PSMA-RGS using the drop-in gamma probe.
Time frame: Day 0 surgery; assessed when final pathology is available (recorded by Day 28)
Plan to share: Undecided — not yet decided
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Niguarda Hospital