RECRUITING

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

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Conditions

Prostate CancerProstate AdenocarcinomaProstate Cancer MetastaticCastration-resistant Prostate CancerCirculating Tumor Cells (CTC)Androgen-receptor signaling inhibitors (ARSI)Metastatic castration resistant prostate cancer (mCRPC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-13
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06141993

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
  2. 2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.
  3. 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. 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. 5. Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy.
  6. 6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:
  7. 1. Consecutive PSA rises at least 2 weeks apart
  8. 2. Minimum PSA of 1.0 ng/dl prior to entry
  9. 7. Age \> 18 years.
  10. 8. Ability to understand and the willingness to sign a written informed consent document.
  1. 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. 2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.
  3. 3. Life expectancy \< 6 months
  4. 4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.

Contacts and Locations

Study Contact

Kellie Shobe, MS, BSN, RN
CONTACT
919-684-8299
kellie.shobe@duke.edu
Monika Anand, PhD
CONTACT
919-681-8838
monika.anand@duke.edu

Principal Investigator

Andrew Armstrong, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Duke University

  • Andrew Armstrong, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-05-13
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-05-13
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer Metastatic
  • Castration-resistant Prostate Cancer