ArtemiCoffee in Patients With Rising PSA

Launched by ZIN W MYINT · Jul 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ArtemiCoffee, which is made from the plant Artemisia annua. It's designed for men who have prostate cancer and are experiencing a rise in their prostate-specific antigen (PSA) levels, which can indicate that the cancer is returning or progressing. The goal of this trial is to see if ArtemiCoffee can help lower these rising PSA levels in patients who have already received treatment for their cancer, such as surgery or radiation.

To participate in this study, men must be at least 18 years old and have completed their initial treatment for prostate cancer. They should also be experiencing a rise in PSA but not have any signs of metastatic disease, meaning the cancer hasn't spread to other parts of the body. Participants will be closely monitored during the trial, and they will need to sign an informed consent form to confirm they understand the study and agree to take part. This trial offers hope for men facing biochemical recurrence of prostate cancer, as it tests a new approach that could improve their treatment options.

Gender

MALE

Eligibility criteria

• 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