COMPASS Study for Metastatic Castration-resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CXCR2 as a biomarker.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
COMPASS: Correlative COMPAnion Study to Predict SYNERGY-201 Clinical Trial Responders
Overview
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.
Interventions
- Diagnostic test CXCR2 as a biomarker
CXCR2 biomarker expression will be measured in tumor and immune cell samples
Primary outcome measures
- 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)]
- Number of participants with Immune cell CXCR2 biomarker expression associated with clinical benefit (CB) [Time frame: 6 months from Cycle 1 Day 1 (each cycle is 21 days)]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
- Rogel Cancer Center — Ann Arbor
- Duke University — Durham
Identifiers
NCT: NCT07050433 · Pro00115687