We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tumor Microenvironment Analysis of Prostate Cancer Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05304858
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Janssen Pharmaceuticals
Information provided by (Responsible Party):
Mark Stein, Columbia University

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.

Condition or disease Intervention/treatment
Recurrent Prostate Cancer Procedure: Biopsy

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis
Actual Study Start Date : September 15, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
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
Standard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental.




Primary Outcome Measures :
  1. Single-Cell RNA Sequencing (scRNAseq) [ Time Frame: 2 years ]
    Profiling of the tumor microenvironment (TME) through single-cell RNA sequencing (scRNAseq) for deep profiling of the local immune microenvironment in the tumor.

  2. CyTOF high-parametric mass cytometry [ Time Frame: 2 years ]
    CyTOF high-parametric mass cytometry for comprehensive profiling of the tumor and the tumor-immune microenvironment at a larger scale.

  3. Multiplex Immunofluorescence [ Time Frame: 2 years ]
    Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment.

  4. Characterization of the expression and receptor density of prostate lineage antigens [ Time Frame: 2 years ]
    Tumor tissue will be examined through genetic tests in order to determine gene expression of the tumor cells


Biospecimen Retention:   Samples With DNA
In this study, researchers may perform whole genome sequencing and RNA sequencing on tissue samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male adults age 18 or older diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304858


Contacts
Layout table for location contacts
Contact: Mark N Stein, MD 212-305-5874 mns2146@cumc.columbia.edu
Contact: Research Nurse Navigator 212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Locations
Layout table for location information
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Research Nurse Navigator    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Janssen Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Mark N Stein, MD Columbia University
Layout table for additonal information
Responsible Party: Mark Stein, Associate Professor of Medicine at the Columbia University Medical Center, Columbia University
ClinicalTrials.gov Identifier: NCT05304858    
Other Study ID Numbers: AAAT2169
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark Stein, Columbia University:
Metastasis
Prostate Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplastic Processes
Pathologic Processes