COMPASS Study for Metastatic Castration-resistant Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Duke University
Study ID
NCT07050433
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CXCR2 as a biomarker — DIAGNOSTIC_TEST
    CXCR2 biomarker expression will be measured in tumor and immune cell samples

Study Details

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.

Key Dates

Start date
Aug 7, 2025
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Number of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB) [ Time Frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158
Kelly Fitzgerald, MD
[email protected]
415-476-4616
Rahul Aggarwal, MD
[email protected]
(415) 476-4616
Rogel Cancer CenterAnn ArborMichigan48109-2800
Zachery Reichert, MD
[email protected]
800-865-1125
Zachery Reichert, MD
[email protected]
800-865-1125
Duke UniversityDurhamNorth Carolina27705
Monika Monika Anand, PhD
[email protected]
919-681-8838
Kellie Shobe, MS, BSN, RN
[email protected]
919-684-8299

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CARogel Cancer Center· Ann Arbor, MIDuke University· Durham, NC

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