Clinical Research Directory

Inclusion Criteria: * Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed) * Biochemical PSA recurrence * Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status ≤3 * Total bilirubin ≤ 1.5 x upper normal limit (ULN), and AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3.0 x ULN * Patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as determined by the treating physician are eligible. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Any radiological evidence of metastatic disease (determined by standard of care computed tomography (CT) scans of abdomen, pelvis, chest, whole body bone scan or Axium PET/CT scan or prostate specific membrane antigen (PSMA) PET/CT scan). * Receipt of prior cytotoxic chemotherapy for recurrent prostate cancer * Use of androgen deprivation therapy (for example, bicalutamide, flutamide, nilutamide, or leuprolide acetate) concurrently or within the previous 3 months. * Uncontrolled intercurrent illness such as active infections. Other illnesses will be evaluated and eligibility status determined at the discretion of the treating physician and the investigator. * Psychiatric illness/social situations that would limit compliance with study requirements. * Concomitant use of nevirapine, ritonavir, and strong UGT inducers or strong UGT inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib * Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin