Clinical trial NCT06141993: ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Official title: Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
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)
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
name: Memorial Sloan Kettering Cancer Center
First posted: 2023-11-21
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Comparison of progression-free survival (PFS) between biomarker positive and negative participants
timeFrame: Through completion of participant participation, up to 3 years
Secondary outcomes:
measure: Comparison of overall survival between biomarker positive and negative participants
timeFrame: Through completion of participant participation, up to 3 years
measure: Comparison of the proportion of participants that achieve a >50% PSA declines from baseline between biomarker positive and negative participants
timeFrame: Through completion of participant participation, up to 3 years
measure: Comparison of soft tissue response between biomarker positive and negative participants
timeFrame: Through completion of participant participation, up to 3 years
measure: Comparison of duration of therapy between biomarker positive and negative participants
timeFrame: Through discontinuation of current therapy, up to 3 years
measure: Number of emergent molecular lesions in CTCs that consistently emerge during subsequent AR therapy progression in men with mCRPC
timeFrame: At disease progression, up to 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Duke University
name: Andrew Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References: