Analyzing the tumor environment in metastatic prostate cancer
Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis
This study is trying to learn more about the environment around prostate cancer tumors in men with advanced disease by looking at tissue samples to help find new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05304858 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are males aged 18 and older with histologically proven metastatic adenocarcinoma of the prostate.
Not a fit: Patients without evidence of metastatic disease or those with non-prostate cancer-related conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to the development of novel therapies targeting the tumor microenvironment in metastatic prostate cancer.
How similar studies have performed: Other studies have shown promise in analyzing the tumor microenvironment in various cancers, suggesting potential success for this approach in prostate cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.