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Measuring the CXCR2 Biomarker to Predict Clinical Benefit in Metastatic Castration-Resistant Prostate Cancer Patients Receiving SX-682 plus Enzalutamide in the SYNERGY-201 Trial, COMPASS Trial
Trial Status: active
This clinical trial studies whether measuring the CXCR2 biomarker can predict who will receive clinical benefit from the drug combination SX-682 plus enzalutamide in patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) who are receiving the drug combination in the NCT06228053; Duke Institutional Review Board # Pro00113209 (SYNERGY-201) trial. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Research has shown that prostate cancer patients with the CXCR2 biomarker may develop metastatic disease sooner and may also develop resistance to certain therapies. Researchers hope that by measuring the CXCR2 biomarker in metastatic castration-resistant prostate cancer patients receiving SX-682 plus enzalutamide in the SYNERGY-201 trial they will be able to learn more about the biomarker, which may help predict who will receive clinical benefit from the drug combination.
Inclusion Criteria
Willing and able to provide written informed consent for this study and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information
Age ≥ 18
Participating in the SYNERGY-201 clinical trial
Exclusion Criteria
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07050433.
I. To associate tumor and immune CXCR2 biomarker expression with clinical benefit (CB) to CXCR1/2 inhibitor SX-682 (SX-682) plus enzalutamide in the SYNERGY-201 trial.
EXPLORATORY OBJECTIVES:
I. To associate tumor and immune cell CXCR2 biomarker expression with tumor androgen receptor (AR) detection and neuroendocrine prostate cancer (NEPC) phenotypes at baseline and over time.
II. To estimate the progression free survival (PFS) and overall survival (OS) distributions for tumor and/or immune cell CXCR2 expression.
III. To explore the prognostic importance of tumor or immune cell CXCR2 expression in predicting OS and PFS.
IV. To describe the changes in CXCR2 at baseline and over time for the longitudinally collected specimens (metastatic or liquid).
V. To associate tumor genetic alterations with CXCR2 expression in the tumor or tumor microenvironment at baseline and with clinical efficacy outcomes.
OUTLINE:
Patients undergo blood sample collection with CXCR2 biomarker analysis before treatment, at cycle 3 of SX-682 plus enzalutamide treatment, and at progression. Patients may also undergo metastatic tumor biopsy before treatment and at cycle 3 of treatment.
After completion of study intervention, patients are followed up under the SYNERGY-201 trial.
