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RECRUITINGOBSERVATIONAL

COMPASS Study for Metastatic Castration-resistant Prostate Cancer

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Willing and able to provide written willing to sign a consent form for this study and HIPAA authorization for the release of personal health information. - Age \>18 - Participating in the SYNGERY-201 clinical trial. Who Should NOT Join This Trial: - 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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DIAGNOSTIC_TEST

CXCR2 as a biomarker

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

Locations (1)

Duke University
Durham, North Carolina, United States