Prostate CancerPhase 2NCT05478239
ArtemiCoffee in Patients With Rising PSA
A Phase 2 study testing ArtemiCoffee in people with Prostate Cancer, run by Zin W Myint at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ArtemiCoffee
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2023to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This is an open-labeled phase II study of Artemisia annua (Aa) decaf coffee in patients with biochemical recurrence of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- ArtemiCoffee
- Keywords
- Artemisia annua, Biochemically recurrent, Prostate-specific antigen
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtemiCoffeeDrug
Also called Artemisia annua (Aa) coffee
3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer patients | Experimental | Men with biochemical recurrence of prostate cancer after initial local therapy. Receives: Drug: ArtemiCoffee |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start11 Aug 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zin W Myint
- Sponsor type
- University, hospital or other
- Collaborators
- ArtemiLife
- Responsible party
- Sponsor-investigator, Zin W Myint, University of Kentucky
- Investigators
- Zin Myint, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478239
- Sponsor's protocol ID
- MCC-22-GU-79
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of ArtemiCoffee for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
- ClinicalTrials.gov ID
- NCT05478239
- Acronym / sponsor ID
- MCC-22-GU-79
- Conditions
- Prostate Cancer
- Keywords
- Artemisia annua, Biochemically recurrent, Prostate-specific antigen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zin W MyintUniversity, hospital or other
- Collaborators
- ArtemiLife
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer patients | Experimental | Drug: ArtemiCoffeeMen with biochemical recurrence of prostate cancer after initial local therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtemiCoffeeAlso: Artemisia annua (Aa) coffee3 cups of Artemisia annua (Aa) coffee per day (1350mg) for 24 weeks. | Drug | Prostate cancer patients |
Primary outcome
Proportion of patients who achieve a 50% decline in PSA levels
Time frame: 24 weeks
Proportion of patients who achieve greater than 50% decline in PSA within 24- weeks of coffee treatment.
3 secondary outcomes
Change in PSA velocity and slope from pre-treatment to post-treatment
Time frame: 24 weeks (Baseline and 24 weeks)
Percentage change in serial PSA
Time frame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
Percentage change in serial testosterone levels
Time frame: 24 weeks (Baseline, 3-mos, 6-mos and post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zin Myint, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ArtemiCoffee in people with Prostate Cancer, run by Zin W Myint at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve a 50% decline in PSA levels (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.