ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
NCT ID: NCT06141993
Last Updated: 2025-10-15
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
120 participants
OBSERVATIONAL
2024-05-13
2027-04-30
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 with progressive metastatic castration resistant prostate cancer (mCRPC)
Men with progressive metastatic castration resistant prostate cancer (mCRPC) and starting standard of care therapy with a second androgen receptor (AR) inhibitor (typically enzalutamide or abiraterone acetate) will have blood collected for circulating tumor cell (CTC) assessments and other research assessments at baseline, 12 weeks and upon disease progression.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.
3. Prior documented disease progression on one potent AR inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide or combinations of these) in any disease setting (mHSPC, nmCRPC, mCRPC) based on sequential PSA rises or radiographic progression.
4. Planned therapy with either standard of care enzalutamide and/or abiraterone acetate or another potent AR inhibitor (darolutamide, apalutamide if available) within the coming 6 weeks
5. Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy.
6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:
1. Consecutive PSA rises at least 2 weeks apart
2. Minimum PSA of 1.0 ng/dl prior to entry
7. Age \> 18 years.
8. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
1. History of intercurrent or past medical or psychiatric illness including active stage IV malignancy that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.
3. Life expectancy \< 6 months
4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.
18 Years
MALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Memorial Sloan Kettering Cancer Center
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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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Wisconsin-Madison
Madison, Wisconsin, 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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Pro00111532
Identifier Type: -
Identifier Source: org_study_id
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