Prostate CarcinomaNCT07910019
Evaluating Prostate Cancer Patient Natural Killer Cell Function Across Racial Background and Addressing Functional Disparities With Trispecific Killer Engagers
An observational study of Prostate Carcinoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This study collects, stores and analyzes blood specimens and information from people with prostate cancer. This may help researchers understand whether certain white blood cells involved in immunity differs between prostate cancer patients from various racial backgrounds. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Non-Interventional Study
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2026to 30 Nov 2030
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with primary prostate cancer with a planned visit to a University of Minnesota Cancer clinic.
Who may be able to join
- AIM 1:
- Diagnosis (or presumed diagnosis) of primary Prostate cancer
- 18 years of age or older
- Has a planned visit to a University of Minnesota Cancer Clinic
- Willing and able to sign voluntary written consent
Who cannot join
- AIM 1:
- Inability or unwillingness to give written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Nicholas A. Zorko, 612-626-1422, zorko004@umn.edu
Nicholas A. Zorko
About this study
This study collects, stores and analyzes blood specimens and information from people with prostate cancer. This may help researchers understand whether certain white blood cells involved in immunity differs between prostate cancer patients from various racial backgrounds.
Read the detailed description
PRIMARY OBJECTIVES:
- To collect, process, and analyze blood samples from primary prostate cancer patients receiving care at the Masonic Cancer Center.
II. To collect and analyze retrospective and prospective corresponding clinical and laboratory data on disease characterization, treatment, and outcomes.
III. To explore NK cell and broad immune surface marker expressions in prostate cancer patients with diverse racial backgrounds using a 42-marker mass cytometry panel.
IV. To analyze tissue biopsy samples previously collected during the standard of care diagnostic process using multiplex immunofluorescence and spatialomics analysis.
- To develop, produce, and conduct pre-clinical validations of a B7-H3/PSMA TriKE-PACC using in vitro and in vivo assays using de-identified normal donor blood samples.
OUTLINE: This is an observational study.
Patients undergo collection of blood samples and have their medical records reviewed on study. Patients may undergo collection of residual tissue samples, if available, on study.
- Conditions
- Prostate Carcinoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo collection of blood samples and have their medical records reviewed on study. Patients may undergo collection of residual tissue samples, if available, on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline natural cytotoxicity of CSPC and CRPC patients' natural killer cells
Will be evaluated against K562 cells (to which NK cells actively degranulate and kill without cytokine or engager) and prostate cancer cell lines (C4-2, PC3, DU145, and 22RV1) using standard in vitro assays. CSPC and CRPC patient NK cells collected will be compared to age- and race-matched normal donor NK cells, which are a by-product of blood donation. Data will be summarized using descriptive statistics and pairwise comparisons with two-sided paired t-tests.
Measured: Through study completion, an average of 1 year
Broad immune landscape
Mass cytometry will be used to explore the broad immune landscape. CyTOF (Fluidigm), or mass cytometry, is a variation of flow cytometry in which antibodies are labeled with heavy metal ion tags instead of fluorochromes. Readout is by time-of-flight mass spectrometry. The research team have developed and validated a complex NK cell-focused panel containing 42 antibodies to track NK cell characteristics in patient or lab samples. This panel also includes B7H3, to help track potential expression of the target antigen on myeloid cells. The panel allows for in-depth understanding of differences in circulating NK cells from patients of different races versus matched normal donors. Descriptive statistics will be used for comparisons between features of peripheral blood and tissue biopsy samples when applicable.
Measured: Through study completion, an average of 1 year
Analysis of biopsy samples
Existing patient biopsy samples from the time of diagnosis will be analyzed using a multiplex immunofluorescence panel with the CODEX platform specifically designed for analysis of prostate cancer infiltrating immune fractions. Descriptive statistics will be used for comparisons between features of peripheral blood and tissue biopsy samples when applicable.
Measured: Through study completion, an average of 1 year
Effects on NK cells treated with IL-15, camB7-H3 TriKE, scFv PSMA TriKE, or camB7-H3/PSMA TriKE-PACC
Will use descriptive statistics to evaluate effects on NK cells treated with IL-15, camB7-H3 TriKE, scFv PSMA TriKE, or camB7-H3/PSMA TriKE-PACC.
Measured: Through study completion, an average of 1 year
Ability of the 5 treatments to mitigate tumor burden
For the tumor control studies, the ability of the 5 treatments to mitigate tumor burden will be assessed by tumor volume over time. We will compare the differences in tumor volumes on days 21 and 35 across the 3 different groups using repeated measures analysis of variance models and t-tests for pairwise comparisons.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start8 Oct 2026
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Nicholas A Zorko, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910019
- Sponsor's protocol ID
- 2025LS201
- Other IDs
- NCI-2026-02022, 2025LS201, HT9425-25-1-0438
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Prostate Cancer Patient Natural Killer Cell Function Across Racial Background and Addressing Functional Disparities With Trispecific Killer Engagers
- ClinicalTrials.gov ID
- NCT07910019
- Acronym / sponsor ID
- 2025LS201
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 2 Nov 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.
This study collects, stores and analyzes blood specimens and information from people with prostate cancer. This may help researchers understand whether certain white blood cells involved in immunity differs between prostate cancer patients from various racial backgrounds.
Detailed description
PRIMARY OBJECTIVES:
- To collect, process, and analyze blood samples from primary prostate cancer patients receiving care at the Masonic Cancer Center.
II. To collect and analyze retrospective and prospective corresponding clinical and laboratory data on disease characterization, treatment, and outcomes.
III. To explore NK cell and broad immune surface marker expressions in prostate cancer patients with diverse racial backgrounds using a 42-marker mass cytometry panel.
IV. To analyze tissue biopsy samples previously collected during the standard of care diagnostic process using multiplex immunofluorescence and spatialomics analysis.
- To develop, produce, and conduct pre-clinical validations of a B7-H3/PSMA TriKE-PACC using in vitro and in vivo assays using de-identified normal donor blood samples.
OUTLINE: This is an observational study.
Patients undergo collection of blood samples and have their medical records reviewed on study. Patients may undergo collection of residual tissue samples, if available, on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo collection of blood samples and have their medical records reviewed on study. Patients may undergo collection of residual tissue samples, if available, on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary prostate cancer with a planned visit to a University of Minnesota Cancer clinic.
Key inclusion criteria (5 listed)
- AIM 1:
Key exclusion criteria (2 listed)
- AIM 1:
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 |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Baseline natural cytotoxicity of CSPC and CRPC patients' natural killer cells
Time frame: Through study completion, an average of 1 year
Will be evaluated against K562 cells (to which NK cells actively degranulate and kill without cytokine or engager) and prostate cancer cell lines (C4-2, PC3, DU145, and 22RV1) using standard in vitro assays. CSPC and CRPC patient NK cells collected will be compared to age- and race-matched normal donor NK cells, which are a by-product of blood donation. Data will be summarized using descriptive statistics and pairwise comparisons with two-sided paired t-tests.
Broad immune landscape
Time frame: Through study completion, an average of 1 year
Mass cytometry will be used to explore the broad immune landscape. CyTOF (Fluidigm), or mass cytometry, is a variation of flow cytometry in which antibodies are labeled with heavy metal ion tags instead of fluorochromes. Readout is by time-of-flight mass spectrometry. The research team have developed and validated a complex NK cell-focused panel containing 42 antibodies to track NK cell characteristics in patient or lab samples. This panel also includes B7H3, to help track potential expression of the target antigen on myeloid cells. The panel allows for in-depth understanding of differences in circulating NK cells from patients of different races versus matched normal donors. Descriptive statistics will be used for comparisons between features of peripheral blood and tissue biopsy samples when applicable.
Analysis of biopsy samples
Time frame: Through study completion, an average of 1 year
Existing patient biopsy samples from the time of diagnosis will be analyzed using a multiplex immunofluorescence panel with the CODEX platform specifically designed for analysis of prostate cancer infiltrating immune fractions. Descriptive statistics will be used for comparisons between features of peripheral blood and tissue biopsy samples when applicable.
Effects on NK cells treated with IL-15, camB7-H3 TriKE, scFv PSMA TriKE, or camB7-H3/PSMA TriKE-PACC
Time frame: Through study completion, an average of 1 year
Will use descriptive statistics to evaluate effects on NK cells treated with IL-15, camB7-H3 TriKE, scFv PSMA TriKE, or camB7-H3/PSMA TriKE-PACC.
Ability of the 5 treatments to mitigate tumor burden
Time frame: Through study completion, an average of 1 year
For the tumor control studies, the ability of the 5 treatments to mitigate tumor burden will be assessed by tumor volume over time. We will compare the differences in tumor volumes on days 21 and 35 across the 3 different groups using repeated measures analysis of variance models and t-tests for pairwise comparisons.
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 2 Nov 2026.
Related trials for Prostate Carcinoma
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
Not yet recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Castration Resistant Metastatic Prostate Cancer, Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
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.
Nicholas A Zorko principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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 2 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 2 Nov 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline natural cytotoxicity of CSPC and CRPC patients' natural killer cells (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 2 Nov 2026.