TACTIC-P
Targeting Tissue-Resident T Cells for Personalized Immunotherapy and Recurrence Prevention in Patients With Node-Positive Prostate Cancer Undergoing PSMA-Guided Surgery
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Fondazione Regionale per la Ricerca Biomedica
interventional
12
1 country
1
Study Start
October 1, 2026
Actual (reported)Primary Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2026
Actual (reported)October 10, 2026
Actual (reported)October 19, 2026
Actual (reported)August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
Day 0 surgery; assessed when final pathology is available (recorded by Day 28)
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162, Italy
First Submitted
October 10, 2026
First Posted
October 19, 2026
Study Start
October 1, 2026
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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