Using blood tests to predict treatment response in advanced prostate cancer
Clinical Validation of a Circulating Tumor Cell AR Therapy Resistance Assay in Men With Metastatic Castration Resistant Prostate Cancer (ARCTIC)
This study is testing if blood tests can help predict how well men with advanced prostate cancer will respond to their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT06141993 on ClinicalTrials.gov |
What this trial studies
This observational study will track men with metastatic castration-resistant prostate cancer as they undergo standard treatment to identify biomarkers in circulating tumor cells (CTCs) that may indicate their response to therapy. By analyzing blood samples and archival tumor biopsy samples, researchers aim to compare the genetic and protein profiles of patients who respond well to treatment against those who do not. The goal is to enhance the understanding of how certain biomarkers can predict treatment outcomes, potentially leading to more personalized cancer care.
Who should consider this trial
Good fit: Ideal candidates for this study are men diagnosed with metastatic castration-resistant prostate cancer who have experienced disease progression on prior androgen receptor inhibitors.
Not a fit: Patients with small cell or neuroendocrine tumors of the prostate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with advanced prostate cancer by identifying who is likely to benefit from specific therapies.
How similar studies have performed: Other studies have shown promise in using biomarkers to predict treatment responses in various cancers, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 2 other locations
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Armstrong, MD — Duke University
- Study coordinator: Kellie Shobe, MS, BSN, RN
- Email: kellie.shobe@duke.edu
- Phone: 919-684-8299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.