COMPASS Study for Metastatic Castration-resistant Prostate Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: CXCR2 as a biomarker

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Monika Anand, PhD; Phone Number: 919-681-8838; Email: monika.anand@duke.edu
• Study Contact Backup: Name: Kellie Shobe, MS, BSN, RN; Phone Number: 919-684-8299; Email: kellie.shobe@duke.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • UCSF Helen Diller Family Comprehensive Cancer Center
      • Contact: Kelly Fitzgerald, MD; Phone Number: 415-476-4616; Email: Kelly.Fitzgerald@ucsf.edu
      • Contact: Rahul Aggarwal, MD; Phone Number: (415) 476-4616; Email: rahul.aggarwal@ucsf.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-2800
      • Recruiting
      • Rogel Cancer Center
      • Contact: Zachery Reichert, MD; Phone Number: 800-865-1125; Email: zreiche@med.umich.edu
      • Contact: Zachery Reichert, MD; Phone Number: 800-865-1125; Email: CancerAnswerLine@med.umich.edu
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University
      • Contact: Kellie Shobe, MS, BSN, RN; Phone Number: 919-684-8299; Email: kellie.shobe@duke.edu
      • Contact: Monika Monika Anand, PhD; Phone Number: 919-681-8838; Email: monika.anand@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes men with metastatic castration resistant prostate cancer (mCRPC) who are participating in the SYNERGY-201 clinical trial as defined in the eligibility criteria listed below.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: CXCR2 as a biomarker; CXCR2 biomarker expression will be measured in tumor and immune cell samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Tumor CXCR2 biomarker expression associated with clinical benefit (CB)	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.	6 months from Cycle 1 Day 1 (each cycle is 21 days)
Number of participants with Immune cell CXCR2 biomarker expression associated with clinical benefit (CB)	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.	6 months from Cycle 1 Day 1 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with both tumor CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - TP53	The CXCR2 expression in tumor will be dichotomized as present or absent. Each ctDNA genetic alteration (such as TP53 AR genetic alteration) will be categorized as present or absent.	Baseline
Number of participants with both tumor CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - RB1	The CXCR2 expression in tumor will be dichotomized as present or absent. Each ctDNA genetic alteration (such as RB1 AR genetic alteration) will be categorized as present or absent.	Baseline
Number of participants with both tumor CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - PTEN	The CXCR2 expression in tumor will be dichotomized as present or absent. Each ctDNA genetic alteration (such as PTEN AR genetic alteration) will be categorized as present or absent.	Baseline
Number of participants with both tumor CXCR2 expression and NEPC phenotype on biopsy	CXCR2 expression in tumor will be dichotomized as present or absent and NEPC phenotype will be based on the biopsy and categorized as yes or no.	Baseline
Number of participants with both immune cell CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - TP53	The CXCR2 expression in immune cells will be dichotomized as present or absent. Each ctDNA genetic alteration (such as TP53 AR genetic alteration) will be categorized as present or absent.	Baseline
Number of participants with both immune cell CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - RB1	The CXCR2 expression in immune cells will be dichotomized as present or absent. Each ctDNA genetic alteration (such as RB1 AR genetic alteration) will be categorized as present or absent.	Baseline
Number of participants with both immune cell CXCR2 expression and circulating tumor DNA androgen receptor (AR) genetic alterations - PTEN	The CXCR2 expression in immune cells will be dichotomized as present or absent. Each ctDNA genetic alteration (such as PTEN AR genetic alteration) will be categorized as present or absent.	Baseline
Number of participants with both immune cell CXCR2 expression and NEPC phenotype on biopsy	CXCR2 expression in immune cells will be dichotomized as present or absent and NEPC phenotype will be based on the biopsy and categorized as yes or no.	Baseline
Median progression-free survival (PFS) for participants with tumor CXCR2 expression	Median PFS and 95% CI estimated by the Kaplan-Meier approach will be reported by tumor CXCR2 expression (present or absent).	Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median Progression-Free Survival (PFS) for participants with immune cells CXCR2 expression	Median PFS and 95% CI estimated by the Kaplan-Meier approach will be reported by immune cell CXCR2 expression (present or absent).	Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median overall survival (OS) for participants with tumor CXCR2 expression	Median OS and 95% CI estimated by the Kaplan-Meier approach will be reported by tumor CXCR2 expression (present or absent).	Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Median overall survival (OS) for participants with immune cells CXCR2 expression	Median OS and 95% CI estimated by the Kaplan-Meier approach will be reported by immune cell CXCR2 expression (present or absent).	Up to 3 years after Cycle 1 Day 1 (each cycle is 21 days)
Proportion of participants with CXCR2 expression in tumor over time	The proportion of patients with CXCR2 expression in tumor (present or absent) will be reported at C1D1, C3D1, and progression.	Cycle 1 Day 1 (each cycle is 21 days), Cycle 3 Day 1 (each cycle is 21 days), and progression (up to 3 years)
Proportion of participants with CXCR2 expression in immune cells over time	The proportion of patients with CXCR2 expression in immune cells (present or absent) will be reported at C1D1, C3D1, and progression.	Cycle 1 Day 1 (each cycle is 21 days), Cycle 3 Day 1 (each cycle is 21 days), and progression (up to 3 years)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Prostate Cancer Foundation
• Investigators: Principal Investigator: Andrew Armstrong, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 4, 2025
• First Submitted That Met QC Criteria: June 25, 2025
• First Posted (Actual): July 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; SX-682; SYNERGY-201; CXCR2 inhibition
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Pro00115687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes