Clinical trial Recruiting at 4 sites Observational Ages 18 and up Men only

COMPASS for metastatic castration-resistant prostate cancer

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

Run by Duke University · NCT07050433 · Data updated 2026-11-12

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 typeObservational
Ages18 Years and up
SexMen only
Enrollment48 (estimated)
SponsorDuke University
Academic / other
Locations4 sites (San Francisco, California and 3 other locations)
StatusRecruiting
StartedAugust 7, 2025
Main results expectedJuly 1, 2027
Study endsJanuary 1, 2028
Registry record updatedAugust 27, 2026
Trial IDNCT07050433 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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
  • University of Wisconsin Carbone Cancer Center
    Madison, Wisconsin, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.