Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
48 participants
OBSERVATIONAL
2025-08-07
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
CXCR2 as a biomarker
CXCR2 biomarker expression will be measured in tumor and immune cell samples
Interventions
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CXCR2 as a biomarker
CXCR2 biomarker expression will be measured in tumor and immune cell samples
Eligibility Criteria
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Inclusion Criteria
* Age \>18
* Participating in the SYNGERY-201 clinical trial.
Exclusion Criteria
* 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)
18 Years
MALE
No
Sponsors
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Prostate Cancer Foundation
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Andrew Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00115687
Identifier Type: -
Identifier Source: org_study_id
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