Tumor Microenvironment Analysis of Prostate Cancer Metastasis

Launched by COLUMBIA UNIVERSITY · Mar 22, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on studying recurrent prostate cancer, specifically looking at the area around tumors, known as the tumor microenvironment (TME). Researchers want to collect prostate cancer tissue samples from men who have metastatic prostate cancer, which means the cancer has spread beyond the original site. By analyzing these samples, they hope to learn more about the characteristics and behavior of the cancer, which could lead to better treatment options in the future.

To participate in this trial, you need to be a male aged 18 or older with a confirmed diagnosis of prostate cancer that has spread to other parts of the body. You should be in good enough health to undergo a minor procedure to collect tissue samples. If you qualify and choose to participate, you can expect to provide consent for the study and undergo a core needle biopsy, a procedure where a thin needle is used to take tissue samples from the tumor. This trial is currently looking for participants, and it’s a chance to contribute to important research that could help improve care for men with prostate cancer.

Gender

MALE

Eligibility 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