Actively Recruiting
Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Led by Columbia University · Updated on 2026-06-05
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying metastatic prostate cancer in males to better understand the tumor microenvironment (TME), which includes the cells, blood vessels, and other tissues surrounding the tumor. This observational study aims to profile the TME across different metastatic sites and various clinical stages, such as before and after treatments like androgen deprivation therapy, abiraterone, androgen receptor antagonists, or chemotherapy. The study also evaluates the expression and receptor density of prostate lineage antigens that could be targets for future therapies. Participants diagnosed with metastatic castration-resistant prostate cancer will provide prostate cancer tissue samples through biopsies of metastatic sites such as bone, lymph nodes, or organs like the liver. Some participants may also provide tissue from standard surgical procedures like orthopedic or neurosurgery if clinically needed. The tissue collected will be used for genetic and molecular analyses over a two-year period. During the study, participants will undergo tissue collection procedures and have their samples analyzed using advanced techniques such as single-cell RNA sequencing, mass cytometry, and multiplex immunofluorescence. Researchers will measure the characteristics of the tumor microenvironment and prostate lineage antigen expression and receptor density. The study involves ongoing monitoring over two years to understand the tumor environment and its changes across different clinical scenarios.
CONDITIONS
Brief Title
Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to provide written informed consent for the trial.
- Male, aged 18 years or older on day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Histologically proven adenocarcinoma of the prostate or clinical confirmation if pathology is not available.
- Clinical stage N1 or M1.
- Evidence of nodal or distant metastasis confirmed by MRI, CT scan, bone scan, or PET scan.
- Planned specimen collection with core needle biopsy of at least 21 gauge and depth of 5 mm, aiming for 3-8 cores if safe.
- Laboratory safety requirements met: hemoglobin >7 mg/dL, platelet count ≥75,000/mm3, and coagulation parameters within specified limits or stable on anticoagulation therapy.
You will not qualify if you...
- Psychiatric disorder, medical condition, or life circumstance that would interfere with informed consent.
- Acute illness or medical condition that makes specimen collection inadvisable according to the study physician.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single timepoint
Participants undergo biopsy procedures to collect prostate cancer tissue from metastatic sites for tumor microenvironment analysis.
1 visit (in-person) for biopsy
Duration - Up to 2 years
Participants are observed over time to analyze tumor microenvironment and prostate lineage antigen expression in relation to clinical disease progression.
Periodic assessments as per clinical care
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
M
Mark N. Stein, MD
R
Research Nurse Navigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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