ArtemiCoffee for the Treatment of Biochemical Recurrence after Initial Local Therapy in Patients with Prostate Cancer

Inclusion Criteria

• Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed)
• Biochemical PSA recurrence, defined as: * PSA of >= 0.2 ng/ml that has increased above nadir following radical prostatectomy or * PSA increase of 2.0 ng/ml above post-therapy nadir after primary radiotherapy or * PSA >= 0.2 ng/ml after primary radical prostatectomy followed by salvage radiotherapy and or radiation therapy to a localized oligo-metastasis (either bone or lymph nodes) NOTE: PSA measured at two consecutive timepoints (separated by 4 or more weeks) is required in order to demonstrate the requisite increase in PSA
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 3
• Total bilirubin =< 1.5 x upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 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 positron emission tomography [PET]/CT scan or prostate-specific membrane antigen [PSMA] PET/CT scan). Questionable lesions on bone scan will be confirmed by standard of care methods such as plain X-rays or Axium PET/CT scan or PSMA PET/CT, if not previously performed
• 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 inter-current 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
• PSA doubling time of 9 months or less are excluded