Actively Recruiting
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Led by Duke University · Updated on 2025-10-15
120
Participants Needed
3
Research Sites
150 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
U
University of Wisconsin, Madison
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 proteins can predict which patients respond to the cancer treatment they receive. As tumors grow and begin to spread, they may release cells into patients' bloodstream. These cells are called "circulating tumor cells", or CTCs. CTCs can be used to look for differences in "biomarkers" (genes or proteins that may change based on how a person is or is not responding to treatment). The purpose of this research study is to learn whether scientists can use biomarkers from CTCs to predict which tumors will respond to certain hormonal therapies. Participants will have blood collected and provide an archival sample from a previous tumor biopsy. The researchers will compare biomarkers from participants who responded well to treatment to those who responded poorly in order to answer the research question.
CONDITIONS
Official Title
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of adenocarcinoma of the prostate; pure small cell/neuroendocrine tumors are excluded
- Radiographic evidence of metastatic disease by CT, MRI, or PET imaging
- Prior documented disease progression on one potent androgen receptor inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide) in any disease setting
- Planned therapy with standard of care enzalutamide, abiraterone acetate, or another potent androgen receptor inhibitor within 6 weeks
- Castrate levels of testosterone (<50 ng/dl) at most recent assessment and/or ongoing androgen deprivation therapy
- Evidence of disease progression based on rising PSA: consecutive rises at least 2 weeks apart and minimum PSA of 1.0 ng/dl before entry
- Age greater than 18 years
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- History of medical or psychiatric illness including active stage IV malignancy that would make blood drawing difficult or not feasible
- Unwillingness to be followed longitudinally for serial circulating tumor cell biomarker studies
- Life expectancy less than 6 months
- Planned combination therapy with radiation or systemic therapies other than androgen deprivation therapy and bone health agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
3
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
K
Kellie Shobe, MS, BSN, RN
CONTACT
M
Monika Anand, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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