COMPASS Study for Metastatic Castration-resistant Prostate Cancer

May 1, 2026 updated by: Duke University

COMPASS: Correlative COMPAnion Study to Predict SYNERGY-201 Clinical Trial Responders

This study is a companion to the SYNERGY-201 clinical trial (NCT06228053), which investigates SX-682 and enzalutamide in individuals with prostate cancer. Individuals must be participating in SYNERGY-201 in order to participate in this study. The purpose of this companion study is to learn more about biomarkers, particularly a biomarker called CXCR2, and investigate if CXCR2 can predict who will receive benefit from the SYNERGY-201 drug combination. This study will also investigate how CXCR2 and other biomarkers change over time when participants receive the SYNERGY-201 drug combination. CXCR2 is of particular interest because the SYNERGY-201 drug, SX-682, inhibits CXCR2. After participants provide consent, blood samples will be collected for research purposes at three SYNERGY-201 visits (Baseline, Cycle 3 Day 1 and End of Study Drug). Up to 20 participants will also receive tumor biopsies at the Baseline and SYNERGY-201 Cycle 3 Day 1 visits. Clinical and study data collected as part of SYNERGY-201 will also be used for this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Helen Diller Family Comprehensive Cancer Center
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
    • North Carolina
      • Durham, North Carolina, United States, 27705

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes men with metastatic castration resistant prostate cancer (mCRPC) who are participating in the SYNERGY-201 clinical trial as defined in the eligibility criteria listed below.

Description

Inclusion Criteria:

  • Willing and able to provide written informed consent for this study and HIPAA authorization for the release of personal health information.
  • Age >18
  • Participating in the SYNGERY-201 clinical trial.

Exclusion Criteria:

  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
  • History or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the subject's participation for the full duration of the study
  • History or current evidence of any condition, therapy, or laboratory abnormality that is not in the best interest of the subject to participate (in the opinion of the treating investigator)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Men who are participating in the SYNERGY-201 clinical trial (NCT06228053).
Men with metastatic castration resistant prostate cancer (mCRPC) who are participating in the SYNERGY-201 clinical trial (NCT06228053) and who also agree to participate in this study will have blood collected for circulating tumor DNA (ctDNA) and immune cell profiling assessments and other research assessments at baseline, Cycle 3 Day 1 of SYNERGY-201 and at the time of the decision to discontinue the SYNERGY-201 study drug. A subset of up to 20 participants will also undergo tumor biopsies at the baseline and Cycle 3 Day 1 visits of SYNERGY-201.
Diagnostic test: CXCR2 as a biomarker
CXCR2 biomarker expression will be measured in tumor and immune cell samples

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB)
Time Frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days)
The association between tumor CXCR2 (dichotomized as absent or present CXCR2 levels in tumor at baseline as compared to negative control tissue) and CB will be measured using an odds ratio with 95% CI.
6 months from Cycle 1 Day 1 (each cycle is 21 days)
Number of participants with Immune cell CXCR2 biomarker expression associated with clinical benefit (CB)
Time Frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days)
The association between immune cell CXCR2 (dichotomized as present or absent in any myeloid immune cell subset) and CB will be measured using an odds ratio with 95% CI.
6 months from Cycle 1 Day 1 (each cycle is 21 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with both tumor CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - TP53
Time Frame: Baseline
The CXCR2 expression in tumor will be dichotomized as present or absent. Each ctDNA genetic alteration (such as TP53 AR genetic alteration) will be categorized as present or absent.
Baseline
Number of participants with both tumor CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - RB1
Time Frame: Baseline
The CXCR2 expression in tumor will be dichotomized as present or absent. Each ctDNA genetic alteration (such as RB1 AR genetic alteration) will be categorized as present or absent.
Baseline
Number of participants with both tumor CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - PTEN
Time Frame: Baseline
The CXCR2 expression in tumor will be dichotomized as present or absent. Each ctDNA genetic alteration (such as PTEN AR genetic alteration) will be categorized as present or absent.
Baseline
Number of participants with both tumor CXCR2 expression and NEPC phenotype on biopsy
Time Frame: Baseline
CXCR2 expression in tumor will be dichotomized as present or absent and NEPC phenotype will be based on the biopsy and categorized as yes or no.
Baseline
Number of participants with both immune cell CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - TP53
Time Frame: Baseline
The CXCR2 expression in immune cells will be dichotomized as present or absent. Each ctDNA genetic alteration (such as TP53 AR genetic alteration) will be categorized as present or absent.
Baseline
Number of participants with both immune cell CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - RB1
Time Frame: Baseline
The CXCR2 expression in immune cells will be dichotomized as present or absent. Each ctDNA genetic alteration (such as RB1 AR genetic alteration) will be categorized as present or absent.
Baseline
Number of participants with both immune cell CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - PTEN
Time Frame: Baseline
The CXCR2 expression in immune cells will be dichotomized as present or absent. Each ctDNA genetic alteration (such as PTEN AR genetic alteration) will be categorized as present or absent.
Baseline
Number of participants with both immune cell CXCR2 expression and NEPC phenotype on biopsy
Time Frame: Baseline
CXCR2 expression in immune cells will be dichotomized as present or absent and NEPC phenotype will be based on the biopsy and categorized as yes or no.
Baseline
Median progression-free survival (PFS) for participants with tumor CXCR2 expression
Time Frame: Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median PFS and 95% CI estimated by the Kaplan-Meier approach will be reported by tumor CXCR2 expression (present or absent).
Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median Progression-Free Survival (PFS) for participants with immune cells CXCR2 expression
Time Frame: Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median PFS and 95% CI estimated by the Kaplan-Meier approach will be reported by immune cell CXCR2 expression (present or absent).
Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median overall survival (OS) for participants with tumor CXCR2 expression
Time Frame: Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median OS and 95% CI estimated by the Kaplan-Meier approach will be reported by tumor CXCR2 expression (present or absent).
Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median overall survival (OS) for participants with immune cells CXCR2 expression
Time Frame: Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median OS and 95% CI estimated by the Kaplan-Meier approach will be reported by immune cell CXCR2 expression (present or absent).
Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Proportion of participants with CXCR2 expression in tumor over time
Time Frame: Cycle 1 Day 1 (each cycle is 21 days), Cycle 3 Day 1 (each cycle is 21 days), and progression (up to 3 years)
The proportion of patients with CXCR2 expression in tumor (present or absent) will be reported at C1D1, C3D1, and progression.
Cycle 1 Day 1 (each cycle is 21 days), Cycle 3 Day 1 (each cycle is 21 days), and progression (up to 3 years)
Proportion of participants with CXCR2 expression in immune cells over time
Time Frame: Cycle 1 Day 1 (each cycle is 21 days), Cycle 3 Day 1 (each cycle is 21 days), and progression (up to 3 years)
The proportion of patients with CXCR2 expression in immune cells (present or absent) will be reported at C1D1, C3D1, and progression.
Cycle 1 Day 1 (each cycle is 21 days), Cycle 3 Day 1 (each cycle is 21 days), and progression (up to 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prostate Cancer Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Armstrong, MD, Duke 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00115687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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