Tumor Microenvironment Analysis of Prostate Cancer Metastasis
ConditionRecurrent Prostate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Male adults age 18 or older diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Biopsy
Procedure/SurgeryStandard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: TME Analysis1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
Multiplex Immunofluorescence
Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment.
Time frame
2 years4
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
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Janssen Pharmaceuticals
Collaborator
Source ClinicalTrials.gov