This is a single-arm, open-label phase 2 study to evaluate the role of pacritinib for patients with metastatic castrate-resistant prostate cancer that have progressed on ARSI. Patients will receive pacritinib 200 mg twice daily. To be eligible, patients must have a biopsy of a metastatic site within 30 days of treatment that demonstrates positive STAT5 activation status
Patients aged ≥ 18 years.
Histologically or cytologically confirmed prostate adenocarcinoma.
Have current evidence of metastatic disease documented by either bone scan, CT/MRI and/or PSMA PET scan
Have disease that progressed while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) and during or after treatment with at least one androgen receptor signaling inhibitor (ARSI) (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide) for metastatic hormone-sensitive prostate cancer (HSPC) (mHSPC or nmHSPC) or mCRPC.
Patient does not have positive STAT5 activation status in PC core biopsies.
Previously treated with pacritinib.
Use of investigational agents within 28 days prior to randomization.
Use of other prohibited medications within seven days prior to Cycle 1, Day 1 or 5x half-life of the drug, whichever is longer.
Single group
Pacritinib
DrugPacritinib is an oral drug which will be taken daily at a dose of 200 mg twice a day (BID).
Progression-free Survival
Six-month radiographic progression-free survival is defined as the probability that a given subject will be alive and free from radiographic progression per Prostate Cancer Working Group 3 guidelines at 24 weeks.
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