Status:
RECRUITING
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of Wisconsin, Madison
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Brief Summary
This study will follow men with metastatic castration resistant prostate cancer throughout their standard of care treatment for their disease to determine if the presence of different genes or protein...
Eligibility Criteria
Inclusion
- Patients will be eligible for inclusion in this study only if all of the following criteria apply:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
- Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.
- 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.
- 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
- Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy.
- Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:
- Consecutive PSA rises at least 2 weeks apart
- Minimum PSA of 1.0 ng/dl prior to entry
- Age \> 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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).
- Unwillingness to be followed longitudinally for serial CTC biomarker studies.
- Life expectancy \< 6 months
- Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.
Key Trial Info
Start Date :
May 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06141993
Start Date
May 13 2024
End Date
April 1 2027
Last Update
October 15 2025
Active Locations (3)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792