ArtemiCoffee in Patients With Rising PSA

• Sponsor: Zin W Myint (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05478239
• Collaborator: ArtemiLife (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: ArtemiCoffee	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of patients who achieve a 50% decline in PSA levels [24 weeks]

   Proportion of patients who achieve greater than 50% decline in PSA within 24- weeks of coffee treatment.

Secondary Outcome Measures

1. Change in PSA velocity and slope from pre-treatment to post-treatment [24 weeks (Baseline and 24 weeks)]

   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.

2. Percentage change in serial PSA [24 weeks (Baseline, 3-mos, 6-mos and post-treatment)]

   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.

3. Percentage change in serial testosterone levels [24 weeks (Baseline, 3-mos, 6-mos and post-treatment)]

   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.

Other Outcome Measures

1. Change in plasma concentration of artemisinin and dihydroartemisinin [24 weeks (Baseline and 24 weeks)]

   Changes in plasma concentrations of artemisinin and dihydroartemisinin will be compared pre- and post-treatment with Aa decaf coffee using non-parametric paired test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• Zin W Myint
• ArtemiLife

Investigators

• Principal Investigator: Zin Myint, MD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zin W Myint, Assistant Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05478239
• Other Study ID Numbers: MCC-22-GU-79
• First Posted: Jul 28, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zin W Myint, Assistant Professor, University of Kentucky: Artemisia annua; Biochemically recurrent; Prostate-specific antigen
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 28, 2022