NCT05478239CompletedPhase 2
ArtemiCoffee in Patients With Rising PSA
Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
Until now, clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Artesunate has demonstrated anti-tumor activity in both in vivo and in vitro cell lines. It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 25 Jul 2022
- Start date
- 11 Aug 2023
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Zin W Myint
- Diseases
- Prostate cancer
- NCT number
- NCT05478239
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 11 Aug 2023 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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
Other illness
- 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).
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.