ArtemiCoffee in Patients With Rising PSA

  • Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE2
  • Zin W Myint
  • 18 Years -


Study Purpose

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.

Intervention

Drug : ArtemiCoffee


Eligibility Requirements

info icon Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed)

info icon Biochemical PSA recurrence

info icon Age ≥18 years.

info icon Eastern Cooperative Oncology Group (ECOG) performance status ≤3

info icon Total bilirubin ≤ 1.5 x upper normal limit (ULN), and AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3.0 x ULN

info icon 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.

info icon Ability to understand and the willingness to sign a written informed consent document.

info icon 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).

info icon Receipt of prior cytotoxic chemotherapy for recurrent prostate cancer

info icon Use of androgen deprivation therapy (for example, bicalutamide, flutamide, nilutamide, or leuprolide acetate) concurrently or within the previous 3 months.

info icon 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.

info icon Psychiatric illness/social situations that would limit compliance with study requirements.

info icon Concomitant use of nevirapine, ritonavir, and strong UGT inducers or strong UGT inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib

info icon Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin

Recruiting status

Recruiting

Estimated enrollment

30

 
Study start date

Aug 11, 2023

Study end date

Dec 31, 2026

Last updated

Mar 24, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE2

Allocation

Na

 

Sponsor:

Zin W Myint

Collaborator:

ArtemiLife

Investigator:

Zin Myint, MD

NCT05478239

Clinic Location Investigator Distance RECRUITING STATUS Contact