Tumor Microenvironment Analysis of Prostate Cancer Metastasis

NCT05304858 | Recruiting DMC

• 1 other identifier: AAAT2169
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Prostate Cancer

Keywords

Metastasis; Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Procedure: Biopsy

Interventions

Biopsy PROCEDURE

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

TME Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male adults age 18 or older diagnosed with metastatic castration-resistant prostate cancer (mCRPC).

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In this study, researchers may perform whole genome sequencing and RNA sequencing on tissue samples.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Mark N. Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark N. Stein, MD

CONTACT

212-305-5874; mns2146@cumc.columbia.edu

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine at the Columbia University Medical Center

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: September 15, 2021
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)