Prostate Cancer
Conditions
Keywords
Prostate Cancer, SYNERGY-201, SX-682, CXCR2 inhibition
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCXCR2 as a biomarker
CXCR2 biomarker expression will be measured in tumor and immune cell samples
Sponsors
Duke University
Prostate Cancer Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB) | 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) | 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. |
Countries
United States
Contacts
CONTACTKellie Shobe, MS, BSN, RN
CONTACTMonika Anand, PhD
PRINCIPAL_INVESTIGATORAndrew Armstrong, MD
Duke University
Outcome results
None listed