ArtemiCoffee in Patients With Rising PSA

NCT05478239 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-22-GU-79
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Artemisia annua; Biochemically recurrent; Prostate-specific antigen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in PSA velocity and slope from pre-treatment to post-treatment

  24 weeks (Baseline and 24 weeks)

• Percentage change in serial PSA

  24 weeks (Baseline, 3-mos, 6-mos and post-treatment)

• Percentage change in serial testosterone levels

  24 weeks (Baseline, 3-mos, 6-mos and post-treatment)

Other Outcomes (1)

• Change in plasma concentration of artemisinin and dihydroartemisinin

  24 weeks (Baseline and 24 weeks)

Study Arms (1)

Prostate cancer patients

EXPERIMENTAL

Men with biochemical recurrence of prostate cancer after initial local therapy.

Drug: ArtemiCoffee

Interventions

ArtemiCoffee DRUG

3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks.

Also known as: Artemisia annua (Aa) coffee

Prostate cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zin W Myint: lead
• ArtemiLife: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Coffee

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Zin Myint, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: August 11, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)