Tumor Microenvironment Analysis of Prostate Cancer Metastasis

NCT ID: NCT05304858

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2028-02-29

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 including cells, blood vessels, etc., in men with metastatic prostate cancer. The type of research performed on these tissue samples include genetic & molecular analyses.

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 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.

Conditions

Recurrent Prostate Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Biopsy

Intervention Type: PROCEDURE

Standard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental.

Interventions

Biopsy

Standard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Mark Stein

Associate Professor of Medicine at the Columbia University Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark N. Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mark N. Stein, MD

Role: CONTACT

mns2146@cumc.columbia.edu

212-305-5874

Research Nurse Navigator

Role: CONTACT

cancerclinicaltrials@cumc.columbia.edu

212-342-5162

Facility Contacts

Research Nurse Navigator

Role: primary

cancerclinicaltrials@cumc.columbia.edu

212-342-5162

Other Identifiers

AAAT2169

Identifier Type: -

Identifier Source: org_study_id