Analyzing the tumor environment in metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to collect prostate cancer tissue from men with metastatic prostate cancer to analyze the tumor microenvironment (TME), which includes various cells and blood vessels surrounding the tumor. Researchers will perform genetic and molecular analyses on these tissue samples to understand the TME across different metastatic sites and clinical states of the disease. The study will also evaluate the expression and receptor density of prostate lineage antigens that could be targeted for new therapeutic developments. This observational approach will provide insights into the complexities of prostate cancer metastasis.

Why it matters

Who can join: the full rules

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 it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Mark N. Stein, MD — Columbia University
• Study coordinator: Mark N. Stein, MD
• Email: mns2146@cumc.columbia.edu
• Phone: 212-305-5874

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.