COMPASS for metastatic castration-resistant prostate cancer
COMPASS: Correlative COMPAnion Study to Predict SYNERGY-201 Clinical Trial Responders
This companion study tests whether a biomarker called CXCR2 in blood or tumor tissue can predict who benefits from the SYNERGY-201 drug combination (SX-682 plus enzalutamide) in people with metastatic castration‑resistant prostate cancer who are enrolled in SYNERGY-201.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Duke University Academic / other |
| Locations | 3 sites (San Francisco, California and 2 other locations) |
| Trial ID | NCT07050433 on ClinicalTrials.gov |
What this trial studies
COMPASS is an observational companion study to the SYNERGY-201 treatment trial that enrolls only participants already on SYNERGY-201. Researchers will collect blood samples at Baseline, Cycle 3 Day 1, and End of Study Drug to measure CXCR2 and other biomarkers, and up to 20 participants may undergo tumor biopsies at Baseline and Cycle 3 Day 1. The study will track how these biomarkers change over time with treatment and correlate biomarker levels with clinical responses. Data are intended to identify whether CXCR2 can serve as a predictive marker for benefit from SX-682 plus enzalutamide.
Who should consider this trial
Good fit: Ideal candidates are adults (over 18) with metastatic castration‑resistant prostate cancer who are already enrolled in the SYNERGY‑201 trial and willing to provide blood samples and, if asked, tumor biopsies.
Not a fit: Patients not enrolled in SYNERGY‑201, those unwilling or unable to provide consent or the required blood/tissue samples, or those with medical conditions that would confound biomarker measurements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could help identify which patients are most likely to benefit from the SX-682 plus enzalutamide combination, enabling more personalized treatment decisions.
How similar studies have performed: Companion biomarker studies are commonly used and prior research links CXCR2 signaling to cancer biology, but using CXCR2 specifically to predict response to SX-682 plus enzalutamide is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
San Francisco, California and 2 other locations
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States (Recruiting)
- Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Armstrong, MD — Duke University
- Study coordinator: Kellie Shobe, MS, BSN, RN
- Email: kellie.shobe@duke.edu
- Phone: 919-684-8299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.