Recruiting

Prostate Cancer

Sponsor:

Columbia University

Code:

NCT05304858

Conditions

Recurrent Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy

Study Details

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

Study ID

NCT05304858

Start date

Sep 15, 2021

Status verified date

Jun, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biopsy

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

Primary outcome measure

  • Single-Cell RNA Sequencing (scRNAseq) [ Time Frame: 2 years ]
  • CyTOF high-parametric mass cytometry [ Time Frame: 2 years ]
  • Multiplex Immunofluorescence [ Time Frame: 2 years ]
  • Characterization of the expression and receptor density of prostate lineage antigens [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Mark N. Stein, MD

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

Research Nurse Navigator

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

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Research Nurse Navigator

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

More Information

Sponsor

Columbia University

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Metastasis
  • Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-05.