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

NCT06141993 | Recruiting

• 1 other identifier: Pro00111532
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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 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

Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Metastatic; Castration-resistant Prostate Cancer

Keywords

Circulating Tumor Cells (CTC); Androgen-receptor signaling inhibitors (ARSI); Metastatic castration resistant prostate cancer (mCRPC)

Outcome Measures

Primary Outcomes (1)

• Comparison of progression-free survival (PFS) between biomarker positive and negative participants

  PFS which is defined as the time from date of study enrollment to radiographic or clinical progression or death. Radiographic progression will be defined by Prostate Cancer Working Group 3 (PCWG3) criteria for soft tissue and bone metastases and will not include PSA changes alone. Clinical progression will be defined as clinical deterioration requiring a change in therapy, such as a pathologic fracture or symptomatic skeletal event or pain progression in the absence of imaging progression.

  Through completion of participant participation, up to 3 years

Secondary Outcomes (5)

• Comparison of overall survival between biomarker positive and negative participants

  Through completion of participant participation, up to 3 years

• Comparison of the proportion of participants that achieve a >50% PSA declines from baseline between biomarker positive and negative participants

  Through completion of participant participation, up to 3 years

• Comparison of soft tissue response between biomarker positive and negative participants

  Through completion of participant participation, up to 3 years

• Comparison of duration of therapy between biomarker positive and negative participants

  Through discontinuation of current therapy, up to 3 years

• Number of emergent molecular lesions in CTCs that consistently emerge during subsequent AR therapy progression in men with mCRPC

  At disease progression, up to 3 years

Study Arms (1)

Men with progressive metastatic castration resistant prostate cancer (mCRPC)

Men with progressive metastatic castration resistant prostate cancer (mCRPC) and starting standard of care therapy with a second androgen receptor (AR) inhibitor (typically enzalutamide or abiraterone acetate) will have blood collected for circulating tumor cell (CTC) assessments and other research assessments at baseline, 12 weeks and upon disease progression.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes men with progressive metastatic castration resistant prostate cancer (mCRPC) as defined in the eligibility criteria listed below. Participants will enroll at one of three locations: Duke University, University of Wisconsin Madison and Memorial Sloan Kettering Cancer Center.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• University of Wisconsin, Madison: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Armstrong, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kellie Shobe, MS, BSN, RN

CONTACT

919-684-8299; kellie.shobe@duke.edu

Monika Anand, PhD

CONTACT

919-681-8838; monika.anand@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 21, 2023
• Study Start: May 13, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)