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| Name | Class |
|---|---|
| Janssen Pharmaceuticals | INDUSTRY |
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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.
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 sites of metastasis in males with metastatic prostate cancer. The TME is comprised of proliferating tumor cells, the tumor stroma, blood vessels, infiltrating inflammatory cells and a variety of associated tissue cells. This study will enable analysis of the prostate TME in the context of different sites of metastasis as well as a variety of clinical states of disease (i.e no prior androgen deprivation therapy, progression on abiraterone, progression on an androgen receptor (AR) antagonist, or progression on chemotherapy etc). Furthermore, the expression and receptor density of prostate lineage antigens that can be targeted for development of novel therapeutics for prostate cancer will be evaluated in parallel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TME Analysis | Participants who have been diagnosed with metastatic castration-resistant prostate cancer (mCRPC) will volunteer for a biopsy of a site in the body that contains prostate cancer, such as a bone, a lymph node or an organ such as the liver OR are planned to undergo standard of care surgical procedures such as orthopedic surgery or neurosurgery based on a subjects clinical needs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biopsy | Procedure | Standard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single-Cell RNA Sequencing (scRNAseq) | Profiling of the tumor microenvironment (TME) through single-cell RNA sequencing (scRNAseq) for deep profiling of the local immune microenvironment in the tumor. | 2 years |
| CyTOF high-parametric mass cytometry | CyTOF high-parametric mass cytometry for comprehensive profiling of the tumor and the tumor-immune microenvironment at a larger scale. | 2 years |
| Multiplex Immunofluorescence | Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment. | 2 years |
| Characterization of the expression and receptor density of prostate lineage antigens | Tumor tissue will be examined through genetic tests in order to determine gene expression of the tumor cells | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Male adults age 18 or older diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark N. Stein, MD | Contact | 212-305-5874 | mns2146@cumc.columbia.edu | |
| Research Nurse Navigator | Contact | 212-342-5162 | cancerclinicaltrials@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark N. Stein, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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In this study, researchers may perform whole genome sequencing and RNA sequencing on tissue samples.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |