PCF Challenge 2023 Correlate Biomarkers for the SYNERGY- 201 Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Kellie Shobe, MS, BSN, RN
kellie.shobe@duke.edu
919-684-8299
Backup
Monika Anand, PhD
monika.anand@duke.edu
919-681-8838
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2026-10
Participants
Target number of participants: 48
Treatments
Men who are participating in the SYNERGY-201 clinical trial (NCT06228053).
Men with metastatic castration resistant prostate cancer (mCRPC) who are participating in the SYNERGY-201 clinical trial (NCT06228053) and who also agree to participate in this study will have blood collected for circulating tumor DNA (ctDNA) and immune cell profiling assessments and other research assessments at baseline, Cycle 3 Day 1 of SYNERGY-201 and at the time of the decision to discontinue the SYNERGY-201 study drug. A subset of up to 20 participants will also undergo tumor biopsies at the baseline and Cycle 3 Day 1 visits of SYNERGY-201.
Related Therapeutic Areas
Sponsors
Collaborators: Prostate Cancer Foundation
Leads: Duke University

This content was sourced from clinicaltrials.gov

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