ArtemiCoffee in Patients With Rising PSA

Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: ArtemiCoffee

Detailed Description

This is an open-labeled phase II study of Artemisia annua (Aa) decaf coffee in patients with biochemical recurrence of prostate cancer.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate cancer patients; Men with biochemical recurrence of prostate cancer after initial local therapy.	Drug: ArtemiCoffee; 3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks.; Other Names: Artemisia annua (Aa) coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who achieve a 50% decline in PSA levels	Proportion of patients who achieve greater than 50% decline in PSA within 24- weeks of coffee treatment.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PSA velocity and slope from pre-treatment to post-treatment	Change in PSA velocity and slope from pre-treatment to post-treatment. Slope and velocity are measured as concentration per unit of time and will have the same units.	24 weeks (Baseline and 24 weeks)
Percentage change in serial PSA	Percentage change in serial PSA from baseline throughout the treatment period. PSA will be assessed at baseline, 3-mos, 6-mos and at a post-treatment follow-up visit.	24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
Percentage change in serial testosterone levels	Percentage change in serial testosterone levels from baseline throughout the treatment period. Testosterone will be assessed at baseline, 3-mos, 6-mos and at a post-treatment follow-up visit.	24 weeks (Baseline, 3-mos, 6-mos and post-treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma concentration of artemisinin and dihydroartemisinin	Changes in plasma concentrations of artemisinin and dihydroartemisinin will be compared pre- and post-treatment with Aa decaf coffee using non-parametric paired test.	24 weeks (Baseline and 24 weeks)

Collaborators and Investigators

• Sponsor: Zin W Myint
• Collaborators: ArtemiLife
• Investigators: Principal Investigator: Zin Myint, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 25, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Artemisia annua; Biochemically recurrent; Prostate-specific antigen
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Plant Preparations; Biological Products; Complex Mixtures; Coffee
• Other Study ID Numbers: MCC-22-GU-79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No