RECRUITING

Tumor Microenvironment Analysis of Prostate Cancer Metastasis

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Conditions

Recurrent Prostate CancerMetastasisProstate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-09-15
Study Completion:2024-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05304858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be willing and able to provide written informed consent for the trial.
  2. * Age ≥18 years of age on day of signing informed consent.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status: 0,1 or 2
  4. * 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.
  5. * Clinical stage N1 or M1
  6. * Evidence of nodal or distant metastasis by MRI/CT scan, bone scan or positron emission tomography (PET) scan
  7. * 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.
  8. * Laboratory tests meet minimum safety requirements:
  9. * Hemoglobin \>7mg/dL
  10. * Platelet count ≥75,000/mm3
  11. * 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).
  1. * 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.
  2. * Acute illness or any medical condition in the judgment of the study physician making specimen collection inadvisable

Contacts and Locations

Study Contact

Mark N. Stein, MD
CONTACT
212-305-5874
mns2146@cumc.columbia.edu
Research Nurse Navigator
CONTACT
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Mark N. Stein, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Mark N. Stein, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15
Study Completion Date2024-07

Study Record Updates

Study Start Date2021-09-15
Study Completion Date2024-07

Terms related to this study

Keywords Provided by Researchers

  • Metastasis
  • Prostate Cancer

Additional Relevant MeSH Terms

  • Recurrent Prostate Cancer