Recurrent Prostate CancerNCT05304858
Tumor Microenvironment Analysis of Prostate Cancer Metastasis
An observational study of Recurrent Prostate Cancer, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Recurrent Prostate Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male adults age 18 or older diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
Who may be able to join
- 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
Show all 11Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Research Nurse Navigator, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
About this study
Official title: Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis
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.
Read the 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.
- Conditions
- Recurrent Prostate Cancer
- Being tested
- Biopsy
- Keywords
- Metastasis, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Standard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
Multiplex Immunofluorescence
Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment.
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Sep 2021
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Principal investigator, Mark Stein, Columbia University
- Investigators
- Mark N. Stein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304858
- Sponsor's protocol ID
- AAAT2169
- Status last verified
- Jun 2026
- First submitted
- 22 Mar 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis
- ClinicalTrials.gov ID
- NCT05304858
- Acronym / sponsor ID
- AAAT2169
- Conditions
- Recurrent Prostate Cancer
- Keywords
- Metastasis, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TME Analysis | – | Procedure: BiopsyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male adults age 18 or older diagnosed with metastatic castration-resistant prostate cancer (mCRPC).
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyStandard of care surgical procedures to collect prostate cancer tissue from men with metastatic prostate cancers. Non-experimental. | Procedure or surgery | TME Analysis |
Primary outcome
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.
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.
Multiplex Immunofluorescence
Time frame: 2 years
Multiplex immunofluorescence using Vectra multispectral microscope for high throughput spatial analysis of the tumor microenvironment.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark N. Stein, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Prostate Cancer, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark N. Stein, MD (212-305-5874, mns2146@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-Cell RNA Sequencing (scRNAseq) (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.