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Search / Trial NCT07050433

Correlate Biomarkers for the SYNERGY- 201 Study

Launched by DUKE UNIVERSITY · Jun 25, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Prostate Cancer Synergy 201 Sx 682 Cxcr2 Inhibition

ClinConnect Summary

This study is designed to learn more about certain markers in the blood and tumors—called biomarkers—that might help doctors understand who benefits most from a new combination of medicines being tested for prostate cancer. Specifically, the study focuses on a biomarker called CXCR2, which is involved in how the body responds to one of the drugs in the main SYNERGY-201 trial. By studying CXCR2 and other markers over time, researchers hope to better predict how well the treatment will work for different patients.

To join this study, you must already be taking part in the SYNERGY-201 trial, which involves treatment with the drugs SX-682 and enzalutamide for prostate cancer. Participants will be asked to give blood samples at three times during their treatment and, for some, small tissue samples (biopsies) from their tumor at two points. The study will also use health information collected during SYNERGY-201. This research is currently not open for enrollment and is for men over 18 who can provide consent and meet the main trial’s requirements. The goal is to improve understanding of how these medicines work and who might benefit most from them.

Gender

MALE

Eligibility 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)

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Andrew Armstrong, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported