COMPASS Study for Metastatic Castration-resistant Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CXCR2 as a biomarker

Diagnostic Test

CXCR2 biomarker expression will be measured in tumor and immune cell samples

Primary outcomes

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.
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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kellie Shobe, MS, BSN, RN

CONTACT

[email protected]

919-684-8299

Monika Anand, PhD

CONTACT

[email protected]

919-681-8838

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Prostate Cancer Foundation

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Jul 3, 2025
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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