Actively Recruiting
Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)
Led by Duke University · Updated on 2025-10-15
120
Participants Needed
3
Research Sites
N/A
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
Researchers are studying men with metastatic castration resistant prostate cancer (mCRPC) to see if certain genes or proteins found in circulating tumor cells (CTCs) can predict how well patients respond to hormonal therapies. The study aims to compare biomarkers from patients who respond well to treatment with those who do not, helping to understand resistance to androgen receptor inhibitors. This observational study focuses on men receiving standard care for their advanced prostate cancer. Men with progressive mCRPC starting standard treatment with second-generation androgen receptor inhibitors, such as enzalutamide or abiraterone acetate, will have blood samples collected at the start of treatment, after 12 weeks, and when their disease progresses. Researchers will analyze circulating tumor cells and other biomarkers over time to evaluate resistance to therapy. Participants will also provide an archival tumor biopsy sample for comparison. During the study, participants will undergo regular blood draws to assess biomarkers related to treatment response. Researchers will monitor progression-free survival, overall survival, PSA decline, soft tissue response, and therapy duration up to three years. The study involves close follow-up to observe molecular changes in circulating tumor cells during treatment progression, helping to advance understanding of prostate cancer resistance.
CONDITIONS
Brief 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 adenocarcinoma of the prostate (excluding pure small cell/neuroendocrine tumors)
- Radiographic evidence of metastatic disease by CT, MRI, or PET imaging
- Prior disease progression on one potent androgen receptor inhibitor such as darolutamide, abiraterone, enzalutamide, or apalutamide
- Planned therapy with enzalutamide, abiraterone acetate, or another potent AR inhibitor within 6 weeks
- Castrate levels of testosterone (<50 ng/dl) or ongoing androgen deprivation therapy
- Evidence of disease progression with consecutive PSA rises at least 2 weeks apart and minimum PSA of 1.0 ng/dl
- Age over 18 years
- Ability and willingness to sign informed consent
You will not qualify if you...
- History of serious medical or psychiatric illness that makes blood draws difficult or not feasible
- Unwillingness to be followed over time for serial circulating tumor cell biomarker studies
- Life expectancy less than 6 months
- Planned combination therapy with radiation or systemic treatments other than androgen deprivation therapy and bone health agents
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants who are starting standard of care therapy with a second androgen receptor inhibitor will have blood collected for circulating tumor cell and other research assessments.
Blood collection at baseline, 12 weeks, and upon disease progression
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
M
Monika Anand, PhD
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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