Tumor Microenvironment Analysis of Prostate Cancer Metastasis

Recurrent Prostate Cancer Clinical Trial

Official title:

Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304858
• Other study ID #: AAAT2169
• Status: Recruiting
• Start date: September 15, 2021
• Est. completion date: July 2024

Study information

• Verified date: September 2023
• Source: Columbia University
• Contact: Mark N. Stein, MD
• Phone: 212-305-5874
• Email: mns2146[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Janssen Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Multiplex Immunofluorescence	Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment.	2 years
Primary	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