Using ArtemiCoffee to treat rising PSA in prostate cancer patients
Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
This study is testing if drinking a special decaf coffee made from Artemisia annua can help lower rising PSA levels in men who have had treatment for prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | imatinib, axitinib, chemotherapy, radiation |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05478239 on ClinicalTrials.gov |
What this trial studies
This phase II interventional study investigates the effects of Artemisia annua decaf coffee, known as ArtemiCoffee, on patients experiencing biochemical recurrence of prostate cancer, indicated by rising prostate-specific antigen (PSA) levels. The study aims to determine whether this herbal treatment can effectively lower PSA levels in men who have previously undergone localized therapy for prostate cancer. Participants must meet specific eligibility criteria, including having completed prostate surgery or radiation therapy and showing no evidence of metastatic disease. The study is open-label, meaning both researchers and participants are aware of the treatment being administered.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have experienced biochemical recurrence of prostate cancer after localized treatment.
Not a fit: Patients with radiological evidence of metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel approach to managing rising PSA levels in prostate cancer patients, potentially delaying disease progression.
How similar studies have performed: While the use of Artemisia annua has shown promise in preclinical studies, this specific approach in treating rising PSA levels in prostate cancer is novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Zin Myint, MD — University of Kentucky
- Study coordinator: Zin W Myint, MD
- Email: zin.myint@uky.edu
- Phone: 8593233964
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.