Prostate CancerTACTIC-PNCT07879820
PSMA-Guided Surgery and Tissue-Resident T-Cell Profiling in Node-Positive Prostate Cancer
A study testing PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection in people with Prostate Cancer, run by Niguarda Hospital at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
Elio Mazzone, MD, +393398431192 ext. +393398431192, eliomazzone@gmail.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection
- Keywords
- Prostate-specific membrane antigen (PSMA), Node-positive prostate cancer; Tissue-resident T cells; Bystander T cells, Tumor microenvironment; Radioguided surgery, Gallium-68 PSMA-11, Robot-assisted radical prostatectomy, Extended pelvic lymph node dissection, Single-cell RNA sequencing, T-cell receptor sequencing, Spatial profiling
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node DissectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PSMA-Guided Surgery and Translational Immune Profiling | Experimental | 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 Receives: Procedure: PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Surgical tissue collected on Day 0; endpoint determined after completion of prespecified molecular and functional analyses during the study period.
Secondary outcomes (1)
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.
Measured: Day 0 surgery; assessed when final pathology is available (recorded by Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start1 Oct 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same 68Ga-PSMA-11 PET/CT, PSMA-radioguided surgery, robot-assisted radical prostatectomy with extended pelvic lymph-node dissection, and translational tissue/blood profiling
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879820
- Sponsor's protocol ID
- 7186
- Other IDs
- 022024R0022
- Acronym
- TACTIC-P
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet decided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Tissue-Resident T Cells for Personalized Immunotherapy and Recurrence Prevention in Patients With Node-Positive Prostate Cancer Undergoing PSMA-Guided Surgery
- ClinicalTrials.gov ID
- NCT07879820
- Acronym / sponsor ID
- TACTIC-P / 7186
- Conditions
- Prostate Cancer
- Keywords
- Prostate-specific membrane antigen (PSMA), Node-positive prostate cancer; Tissue-resident T cells; Bystander T cells, Tumor microenvironment; Radioguided surgery, Gallium-68 PSMA-11, Robot-assisted radical prostatectomy, Extended pelvic lymph node dissection, Single-cell RNA sequencing, T-cell receptor sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- IFOM ETS - The AIRC Institute of Molecular Oncology
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same 68Ga-PSMA-11 PET/CT, PSMA-radioguided surgery, robot-assisted radical prostatectomy with extended pelvic lymph-node dissection, and translational tissue/blood profiling
| Arm | Type | Receives |
|---|---|---|
| PSMA-Guided Surgery and Translational Immune Profiling | Experimental | Procedure: PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node DissectionAll 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node DissectionRetzius-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. | Procedure or surgery | PSMA-Guided Surgery and Translational Immune Profiling |
Primary outcome
Proportion of Evaluable Participants With Successfully Identified and Quantitatively Characterized Functional Pathogen-Specific Bystander Tissue-Resident T Cells
Time frame: Surgical tissue collected on Day 0; endpoint determined after completion of prespecified molecular and functional analyses during the study period.
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.
1 secondary outcome
Pathology-Positive Lymph Nodes Detected Only by 68Ga-PSMA Radioguided Surgery
Time frame: Day 0 surgery; assessed when final pathology is available (recorded by Day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSMA-Radioguided Robot-Assisted Radical Prostatectomy With Extended Pelvic Lymph-Node Dissection in people with Prostate Cancer, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elio Mazzone, MD (+393398431192 ext. +393398431192, elio.mazzone@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Evaluable Participants With Successfully Identified and Quantitatively Characterized Functional Pathogen-Specific Bystander Tissue-Resident T Cells (time frame: Surgical tissue collected on Day 0; endpoint determined after completion of prespecified molecular and functional analyses during the study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.