NCT05304858 · Columbia University
Tumor Microenvironment Analysis of Prostate Cancer Metastasis
What this study is about
The purpose of this study is to collect prostate cancer tissue from males with metastatic prostate cancers in order to study the tumor microenvironment (TME), which is the area surrounding the tumor including cells, blood vessels, etc., in men with metastatic prostate cancer. The type of research performed on these tissue samples include genetic \& molecular analyses.
View original scientific description
The purpose of this study is to collect prostate cancer tissue from males with metastatic prostate cancers in order to study the tumor microenvironment (TME), which is the area surrounding the tumor including cells, blood vessels, etc., in men with metastatic prostate cancer. The type of research performed on these tissue samples include genetic \& molecular analyses.
Interventions
PROCEDURE
Biopsy
Standard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental.
Primary outcome measures
Single-Cell RNA Sequencing (scRNAseq)
Time frame: 2 years
Profiling of the tumor microenvironment (TME) through single-cell RNA sequencing (scRNAseq) for deep profiling of the local immune microenvironment in the tumor.
CyTOF high-parametric mass cytometry
Time frame: 2 years
CyTOF high-parametric mass cytometry for comprehensive profiling of the tumor and the tumor-immune microenvironment at a larger scale.
Multiplex Immunofluorescence
Time frame: 2 years
Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment.
Characterization of the expression and receptor density of prostate lineage antigens
Time frame: 2 years
Tumor tissue will be examined through genetic tests in order to determine gene expression of the tumor cells
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Be willing and able to provide written informed consent for the trial.
- Age ≥18 years of age on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0,1 or 2
- Histologically proven adenocarcinoma of the prostate. (Rarely pathology is not available but if clinical situation confirms prostate cancer - such as prior response to androgen ablation and/or metastatic disease typical of prostate cancer, i.e. involving bone or pelvic/extra pelvic lymph nodes or para-aortic lymph nodes, AND an elevated serum concentration of prostate-specific antigen (PSA) typical of prostate cancer) pathology is not required and patient can be enrolled after discussed with study PI.
- Clinical stage N1 or M1
- Evidence of nodal or distant metastasis by MRI/CT scan, bone scan or positron emission tomography (PET) scan
- Planned specimen from subjects that undergo core needle biopsy must allow for cores of at least 21 gauge with depth of 5 mm. A goal of 3-8 core specimens (3 to 8 passages of the needle into the lesion) will be sought during the procedure, if felt to be safe by the performing physician.
- Laboratory tests meet minimum safety requirements:
- Hemoglobin \>7mg/dL
- Platelet count ≥75,000/mm3
- Coagulation: prothrombin time (PT)/international normalized ratio (INR), Partial thromboplastin time (PTT) ≤ 1.5 upper limit of normal (ULN) (except if on therapeutic anticoagulation in which case the patient can be enrolled if stable and anticoagulation levels are appropriate for their condition per good clinical practice).
Exclusion criteria
- A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the investigators, would make it difficult for a patient to successfully complete the informed consent process.
- Acute illness or any medical condition in the judgment of the study physician making specimen collection inadvisable
Where
- New York, New York
Collaborators
Janssen Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations