ArtemiCoffee in Patients With Rising PSA

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478239
• Other study ID #: MCC-22-GU-79
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: Zin W Myint, MD
• Phone: 8593233964
• Email: zin.myint[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Zin W Myint	ArtemiLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)