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

October 13, 2025 updated by: Duke University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Andrew Armstrong, MD, ScM
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin-Madison
        • Contact:
        • Principal Investigator:
          • Joshua Lang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of progression-free survival (PFS) between biomarker positive and negative participants
Time Frame: Through completion of participant participation, up to 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of emergent molecular lesions in CTCs that consistently emerge during subsequent AR therapy progression in men with mCRPC
Time Frame: At disease progression, up to 3 years
At disease progression, up to 3 years
Comparison of overall survival between biomarker positive and negative participants
Time Frame: Through completion of participant participation, up to 3 years
Overall survival is defined as time from date of study enrollment to date of death or last contact.
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
Time Frame: Through completion of participant participation, up to 3 years
PSA decline will be assessed per PCWG3
Through completion of participant participation, up to 3 years
Comparison of soft tissue response between biomarker positive and negative participants
Time Frame: Through completion of participant participation, up to 3 years
Soft tissue response will be assessed per RECIST 1.1.
Through completion of participant participation, up to 3 years
Comparison of duration of therapy between biomarker positive and negative participants
Time Frame: Through discontinuation of current therapy, up to 3 years
Time from initiation to discontinuation of therapy
Through discontinuation of current therapy, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Memorial Sloan Kettering Cancer Center
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Armstrong, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00111532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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