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Trial Title:
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
NCT ID:
NCT06141993
Condition:
Prostate Cancer
Prostate Adenocarcinoma
Prostate Cancer Metastatic
Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Circulating Tumor Cells (CTC)
Androgen-receptor signaling inhibitors (ARSI)
Metastatic castration resistant prostate cancer (mCRPC)
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Dana Rathkopf, MD
Phone:
646-422-4428
Email:
rathkopd@MSKCC.ORG
Contact backup:
Last name:
Rachel Breitman, RN
Phone:
908-542-3190
Email:
breitmar@mskcc.org
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Julia Hurrelbrink, RN, BSN
Phone:
919-681-1030
Email:
julia.hurrelbrink@duke.edu
Investigator:
Last name:
Andrew Armstrong, MD, ScM
Email:
Principal Investigator
Facility:
Name:
University of Wisconsin-Madison
Address:
City:
Madison
Zip:
53792
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura Ruelle
Phone:
608-890-4800
Email:
laura.ruelle@wisc.edu
Investigator:
Last name:
Joshua Lang, MD
Email:
Principal Investigator
Start date:
May 13, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
University of Wisconsin, Madison
Agency class:
Other
Collaborator:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06141993
