RECRUITING

Correlate Biomarkers for the SYNERGY- 201 Study

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Conditions

Prostate CancerSYNERGY-201SX-682CXCR2 inhibition

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PCF Challenge 2023 Correlate Biomarkers for the SYNERGY- 201 Study

Quick Facts

Study Start:2025-08-07
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07050433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide written informed consent for this study and HIPAA authorization for the release of personal health information.
  2. * Age \>18
  3. * Participating in the SYNGERY-201 clinical trial.
  1. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
  2. * 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
  3. * 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)

Contacts and Locations

Study Contact

Kellie Shobe, MS, BSN, RN
CONTACT
919-684-8299
kellie.shobe@duke.edu
Monika Anand, PhD
CONTACT
919-681-8838
monika.anand@duke.edu

Principal Investigator

Andrew Armstrong, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Andrew Armstrong, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-07
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-08-07
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Prostate Cancer
  • SYNERGY-201
  • SX-682
  • CXCR2 inhibition

Additional Relevant MeSH Terms

  • Prostate Cancer