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

Part of paid clinical trials in New York, New York.

Sponsor
Duke University
Study ID
NCT06141993
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
Oct 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Dana Rathkopf, MD
[email protected]
646-422-4428
Rachel Breitman, RN
[email protected]
908-542-3190
Duke University Medical CenterDurhamNorth Carolina27710
Julia Hurrelbrink, RN, BSN
[email protected]
919-681-1030
Andrew Armstrong, MD, ScM (PRINCIPAL_INVESTIGATOR)
University of Wisconsin-MadisonMadisonWisconsin53792
Laura Ruelle
[email protected]
608-890-4800
Joshua Lang, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Memorial Sloan Kettering Cancer Center· New York, NYDuke University Medical Center· Durham, NCUniversity of Wisconsin-Madison· Madison, WI

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