Status:
RECRUITING
Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Janssen Pharmaceuticals
Conditions:
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
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 i...
Detailed Description
The overall aim of this protocol is to collect prostate cancer tissue from males with metastatic prostate cancers in order to perform comprehensive profiling of the tumor microenvironment (TME) across...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05304858
Start Date
September 15 2021
End Date
February 1 2028
Last Update
April 25 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032