Actively Recruiting
Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Led by Columbia University · Updated on 2025-04-25
16
Participants Needed
1
Research Sites
332 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
J
Janssen Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official 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.
- Be 18 years of age or older on the day of signing informed consent.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Have histologically proven adenocarcinoma of the prostate, or clinical evidence confirming prostate cancer if pathology is unavailable.
- Have clinical stage N1 or M1 prostate cancer.
- Have evidence of nodal or distant metastasis confirmed by MRI, CT scan, bone scan, or PET scan.
- Planned specimen collection must allow for core needle biopsy with at least 21 gauge needle and 5 mm depth, aiming for 3 to 8 core specimens if safe.
- Meet minimum laboratory safety requirements: hemoglobin above 7 mg/dL, platelet count at least 75,000/mm3, and coagulation tests (PT/INR and PTT) within 1.5 times the upper limit of normal unless on stable therapeutic anticoagulation.
You will not qualify if you...
- Have a psychiatric disorder, medical condition, or life circumstance that would make it difficult to complete the informed consent process.
- Have an acute illness or medical condition that makes specimen collection inadvisable according to the study physician.
AI-Screening
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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
CONTACT
R
Research Nurse Navigator
CONTACT
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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