COMPASS Study for Metastatic Castration-resistant Prostate Cancer
COMPASS: Correlative COMPAnion Study to Predict SYNERGY-201 Clinical Trial Responders
1 other identifier
observational
48
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2025
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedStudy Start
First participant enrolled
August 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
May 4, 2026
February 1, 2026
1.9 years
June 4, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB)
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)
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)
Study Arms (1)
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.
Interventions
CXCR2 biomarker expression will be measured in tumor and immune cell samples
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Prostate Cancer Foundationcollaborator
Study Sites (3)
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Rogel Cancer Center
Ann Arbor, Michigan, 48109-2800, United States
Duke University
Durham, North Carolina, 27705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Armstrong, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2025
First Posted
July 3, 2025
Study Start
August 7, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
May 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share