Prostate CancerARCTICNCT06141993
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Duke University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Metastatic
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 May 2024to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients will be eligible for inclusion in this study only if all of the following criteria apply:
- 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.
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- 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.
Who cannot join
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Julia Hurrelbrink, RN, BSN, 919-681-1030, julia.hurrelbrink@duke.edu
Andrew Armstrong, MD, ScM
- Recruiting
University of Wisconsin-Madison
Madison, Wisconsin, 53792
Laura Ruelle, 608-890-4800, laura.ruelle@wisc.edu
Joshua Lang, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Dana Rathkopf, MD, 646-422-4428, rathkopd@MSKCC.ORG
Rachel Breitman, RN, 908-542-3190, breitmar@mskcc.org
About this study
Official title: 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.
- 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)
- Medical subject headings
- Prostatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through completion of participant participation, up to 3 years
Secondary outcomes (5)
Comparison of overall survival between biomarker positive and negative participants
Overall survival is defined as time from date of study enrollment to date of death or last contact.
Measured: 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
PSA decline will be assessed per PCWG3
Measured: Through completion of participant participation, up to 3 years
Comparison of soft tissue response between biomarker positive and negative participants
Soft tissue response will be assessed per RECIST 1.1.
Measured: Through completion of participant participation, up to 3 years
Comparison of duration of therapy between biomarker positive and negative participants
Time from initiation to discontinuation of therapy
Measured: 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
Measured: At disease progression, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start13 May 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141993
- Sponsor's protocol ID
- Pro00111532
- Acronym
- ARCTIC
- Status last verified
- Nov 2026
- First submitted
- 10 Nov 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)
- ClinicalTrials.gov ID
- NCT06141993
- Acronym / sponsor ID
- ARCTIC / Pro00111532
- 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)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, Memorial Sloan Kettering Cancer Center
- Study start
- 13 May 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Patients will be eligible for inclusion in this study only if all of the following criteria apply:
- 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
Key exclusion criteria (5 listed)
- A patient will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Comparison of overall survival between biomarker positive and negative participants
Time frame: 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
Comparison of soft tissue response between biomarker positive and negative participants
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Armstrong, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Prostate Adenocarcinoma, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kellie Shobe, MS, BSN, RN (919-684-8299, kellie.shobe@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of progression-free survival (PFS) between biomarker positive and negative participants (time frame: Through completion of participant participation, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.