Study on Pacritinib for Metastatic Castrate-Resistant Prostate Cancer After Androgen Receptor Treatment
Sponsor: Medical College of Wisconsin
ClinicalTrials ID:NCT07226713
This clinical trial is testing the drug pacritinib for men with metastatic castrate-resistant prostate cancer that has progressed after treatment with androgen receptor signaling inhibitors. Participants will take pacritinib twice daily, and must have a biopsy showing specific cancer cell activity to join the study.
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Program Overview
This study aims to evaluate the effectiveness of pacritinib in treating men with metastatic castrate-resistant prostate cancer that has worsened after previous treatments targeting androgen receptors. Participants will take pacritinib 200 mg twice a day. To qualify, a biopsy from a metastatic site within 30 days before starting treatment must show positive STAT5 activation, indicating specific cancer cell activity.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older.
- Confirmed diagnosis of prostate adenocarcinoma.
- Evidence of cancer spread to other parts of the body, confirmed by scans.
- Cancer that has progressed during or after hormone therapy and treatment with at least one androgen receptor signaling inhibitor.
- Low testosterone levels (less than 50 ng/dL).
- Good overall health with a performance status score of 0-1.
- No previous treatment with JAK2 inhibitors.
- Heart function with an ejection fraction of 50% or higher.
- Adequate organ function based on specific blood tests.
- Willingness to use effective birth control methods during the study and for 30 days after the last dose.
- Ability to understand and sign a consent form.
- Provide a tumor sample from a recent biopsy showing high STAT5 activation levels.
Exclusion Criteria
- No positive STAT5 activation in cancer cell biopsies.
- Previous treatment with pacritinib.
- Use of experimental drugs within 28 days before starting the study.
- Use of certain medications within seven days before starting the study.
- Uncontrolled high blood pressure.
- Severe liver problems.
- Uncontrolled illnesses or conditions that could interfere with the study.
- Recent significant bleeding issues.
- Use of medications that increase bleeding risk or affect heart rhythm within 14 days before starting the study.
- History of serious heart conditions within six months before starting the study.
- Heart rhythm issues or heart failure.
- Conditions affecting the absorption of oral medication.
- Other cancers within three years, except for certain skin cancers.
- Active infections like HIV or hepatitis.
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