Prostate CancerNCT07050433
COMPASS Study for Metastatic Castration-resistant Prostate Cancer
An observational study of Prostate Cancer, run by Duke University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- CXCR2 as a biomarker
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Aug 2025to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Rogel Cancer Center
Ann Arbor, Michigan, 48109-2800
Zachery Reichert, MD, 800-865-1125, zreiche@med.umich.edu
Zachery Reichert, MD, 800-865-1125, CancerAnswerLine@med.umich.edu
- Recruiting
Duke University
Durham, North Carolina, 27705
Monika Monika Anand, PhD, 919-681-8838, monika.anand@duke.edu
Kellie Shobe, MS, BSN, RN, 919-684-8299, kellie.shobe@duke.edu
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Glenn Liu, MD, 800-622-8922, gxl@medicine.wisc.edu
UW Clinical Trial Navigation Team Cancer Connect, 800-622-8922, cancerconnect@uwcarbone.wisc.edu
- Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Kelly Fitzgerald, MD, (415) 476-4616, Kelly.Fitzgerald@ucsf.edu
Rahul Aggarwal, MD, (415) 476-4616, rahul.aggarwal@ucsf.edu
About this study
Official title: 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.
- Conditions
- Prostate Cancer
- Being tested
- CXCR2 as a biomarker
- Keywords
- Prostate Cancer, SYNERGY-201, SX-682, CXCR2 inhibition
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR2 as a biomarkerDiagnostic test
CXCR2 biomarker expression will be measured in tumor and immune cell samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CXCR2 as a biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months from Cycle 1 Day 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start7 Aug 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050433
- Sponsor's protocol ID
- Pro00115687
- Status last verified
- Feb 2026
- First submitted
- 4 Jun 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPASS: Correlative COMPAnion Study to Predict SYNERGY-201 Clinical Trial Responders
- ClinicalTrials.gov ID
- NCT07050433
- Acronym / sponsor ID
- Pro00115687
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, SYNERGY-201, SX-682, CXCR2 inhibition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men who are participating in the SYNERGY-201 clinical trial (NCT06228053). | – | Diagnostic Test: CXCR2 as a biomarkerMen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CXCR2 as a biomarkerCXCR2 biomarker expression will be measured in tumor and immune cell samples | Diagnostic test | Men who are participating in the SYNERGY-201 clinical trial (NCT06228053). |
Primary outcome
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)
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.
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Armstrong, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kellie Shobe, MS, BSN, RN (919-684-8299, kellie.shobe@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.