RecruitingNCT06141993

ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials

Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)


Sponsor

Duke University

Enrollment

120 participants

Start Date

May 13, 2024

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study collects blood-based biomarkers (liquid biopsies) from men with metastatic prostate cancer that has stopped responding to hormone therapy. It aims to understand why some cancers develop resistance to androgen receptor-targeting drugs (ARSIs) and to find markers that predict treatment outcomes. **You may be eligible if...** - You are male with a confirmed diagnosis of prostate adenocarcinoma - You have metastatic disease visible on CT, MRI, or PET scan - Your cancer has previously progressed on at least one strong AR-targeting drug (such as enzalutamide, abiraterone, darolutamide, or apalutamide) - You are about to start a new treatment for your prostate cancer **You may NOT be eligible if...** - You have pure small cell or neuroendocrine prostate cancer - You have not previously received an ARSI therapy - You do not have visible metastatic disease on imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

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

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NCT06141993


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