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

Launched by DUKE UNIVERSITY · Nov 15, 2023

Keywords

ClinConnect Summary

The ARCTIC clinical trial is studying men with advanced prostate cancer that has not responded to standard hormone treatments. Researchers want to find out if certain genes or proteins found in the bloodstream can help predict how well patients will respond to new hormone therapies. As tumors grow, they release small pieces into the blood called circulating tumor cells (CTCs). By examining these cells and comparing the biomarkers (the special genes or proteins) from patients who do well on treatment to those who do not, scientists hope to learn more about which therapies might work best for individual patients.

To participate in this study, men must be at least 18 years old and have a confirmed diagnosis of prostate cancer that has spread. They should have already tried at least one hormone treatment but are still experiencing disease progression, which means their cancer is getting worse. Participants will provide blood samples and a previous tumor sample to help with the research. This study is currently looking for volunteers, and it’s important for participants to be willing to attend follow-ups for ongoing tests. Overall, this trial aims to help improve treatment for men with prostate cancer by understanding how their tumors respond to therapies.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• Patients will be eligible for inclusion in this study only if all of the following criteria apply:
• • 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:
• A patient will not be eligible for inclusion in this study if any of the following criteria apply:
• • 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.