An observational study in Prostate Carcinoma, sponsored by Masonic Cancer Center, University of Minnesota. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Masonic Cancer Center, University of Minnesota · Observational
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.
PRIMARY OBJECTIVES:
I. 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.
V. 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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 45 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 286 studies on the registry; 35 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with primary prostate cancer with a planned visit to a University of Minnesota Cancer clinic.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
AIM 1:
Exclusion Criteria:
AIM 1:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Non-Interventional Study
Non-interventional study
Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Masonic Cancer Center, University of Minnesota →