Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Prostate Cancer, SYNERGY-201, SX-682, CXCR2 inhibition, Prostatic Neoplasms, CXCR2 as a biomarker

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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.

You CAN'T join if...

  • 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)

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Rogel Cancer Center accepting new patients
    Ann Arbor Michigan 48109-2800 United States
  • Duke University accepting new patients
    Durham North Carolina 27705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT07050433
Study Type
Observational
Participants
Expecting 48 study participants
Last Updated