ArtemiCoffee for Prostate Cancer

Overseen By Zin W Myint, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Zin W Myint

Must not be taking: Androgen deprivation, Nevirapine, Ritonavir, others

Disqualifiers: Metastatic disease, Cytotoxic chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a coffee made from *Artemisia annua*, called ArtemiCoffee, to determine if it can lower PSA levels in men whose prostate cancer has returned after surgery or radiation. Researchers hope this coffee might offer a new way to manage recurrent prostate cancer without visible spread. The trial targets men who have experienced a rise in PSA levels after localized treatment for prostate cancer, but without further signs of the disease on scans. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, such as androgen deprivation therapy if taken within the last 3 months, and some other specific drugs like nevirapine, ritonavir, and certain strong inducers or inhibitors. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that ArtemiCoffee is likely to be safe for humans?

Research has shown that Artemisia annua, the plant used in ArtemiCoffee, has produced promising results in lab studies for fighting tumors. These studies suggest that the plant's compounds might help lower PSA levels in prostate cancer patients. While this is encouraging, evidence from human trials is still being gathered.

ArtemiCoffee is currently in a phase 2 trial, which typically tests the treatment's effectiveness and safety in a larger group. Most treatments reaching this phase are generally considered safe, but side effects can still occur.

Currently, complete information on ArtemiCoffee's safety in humans is unavailable. Participants in the trial will contribute to understanding how well people tolerate this treatment. Those considering joining the trial should discuss any concerns with a healthcare professional. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ArtemiCoffee is unique because it is derived from natural compounds found in coffee and artemisinin, which are not typically used in standard prostate cancer treatments like hormone therapy or chemotherapy. Researchers are excited about ArtemiCoffee because it targets cancer cells differently by potentially disrupting their growth with a novel mechanism of action. This could offer a new, less toxic option for men experiencing a recurrence of prostate cancer after initial treatments.

What evidence suggests that ArtemiCoffee might be an effective treatment for prostate cancer?

Research has shown that Artemisia annua, the main ingredient in ArtemiCoffee, fights cancer cells in lab studies. This trial will provide participants with ArtemiCoffee to evaluate its effects on prostate-specific antigen (PSA) levels, which monitor prostate cancer. Some early research suggests that ArtemiCoffee might reduce PSA levels, potentially slowing the progression of prostate cancer in men whose PSA levels have increased after initial treatment. While more research is needed to confirm these effects, the early signs are promising for those experiencing a return of prostate cancer. ^{1 2 4 6 7}

Who Is on the Research Team?

Zin W. Myint

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for men over 18 who've had prostate cancer treatment but now have rising PSA levels without visible cancer spread. They should be relatively healthy, with no recent hormone therapy or certain other drugs, and no serious illnesses that could affect study participation.

Inclusion Criteria

I have completed treatment for prostate cancer through surgery or radiation.

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

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

Exclusion Criteria

I am not taking medications like phenobarbital or rifampin.

I am not taking medications like nevirapine, ritonavir, or strong UGT inducers/inhibitors.

You have a mental health condition or personal circumstances that might make it difficult for you to follow the study's rules and requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Artemisia annua (Aa) decaf coffee for 24 weeks to assess changes in PSA and other biomarkers

24 weeks

Visits at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-treatment PSA and testosterone assessments

4 weeks

1 post-treatment visit

What Are the Treatments Tested in This Trial?

Interventions

• ArtemiCoffee

Trial Overview The trial tests ArtemiCoffee's ability to lower rising PSA in patients with biochemical recurrence of prostate cancer after initial treatments like surgery or radiation. It explores whether this coffee containing Artesunate can slow down the return of cancer signs.

How Is the Trial Designed?

Group I: Prostate cancer patients Experimental Treatment 1 Intervention

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

ArtemiCoffee is already approved in United States, China, European Union for the following indications:

Approved in United States as Artemisia annua extract for:

• Clinical trials for prostate cancer and ovarian cancer recurrence prevention

Approved in China as Artesunate for:

• Malaria treatment
• Clinical trials for various cancers including lung and breast cancer

Approved in European Union as Artemisia annua extract for:

• Clinical trials for various cancers

Who Is Running the Clinical Trial?

Zin W Myint

Lead Sponsor

Trials

3

Recruited

120+

ArtemiLife

Collaborator

Trials

2

Recruited

40+

Published Research Related to This Trial

Artesunate (ART) effectively suppresses the growth of prostatic cancer cells by inducing apoptosis and decreasing androgen receptor (AR) expression, as demonstrated in both in vitro and in vivo studies using 22rv1 cells.

The mechanism of ART's action involves the AR-DNMT3b pathway, where ART enhances the activity of DNA methyltransferase (DNMT3b), suggesting that targeting this pathway could be a promising strategy for treating prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artesunate Suppresses the Growth of Prostatic Cancer Cells through Inhibiting Androgen Receptor. Wang, Z., Wang, C., Wu, Z., et al.[2018]

Artemisinin, an antimalarial drug derived from the sweet wormwood plant, effectively induces the degradation of androgen receptors (AR) in prostate cancer cells, leading to reduced cell proliferation and disrupted androgen responsiveness.

The mechanism involves the activation of AKT-1, which enhances AR ubiquitination and degradation, suggesting that artemisinin could be a promising new therapeutic option for targeting AR levels in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artemisinin disrupts androgen responsiveness of human prostate cancer cells by stimulating the 26S proteasome-mediated degradation of the androgen receptor protein. Steely, AM., Willoughby, JA., Sundar, SN., et al.[2021]

Artesunate (ART) significantly inhibited the growth and proliferation of both therapy-sensitive and docetaxel-resistant prostate cancer cells in a dose- and time-dependent manner, while not affecting normal, non-cancerous cells, indicating its potential safety profile.

ART induced cell cycle arrest and promoted apoptotic cell death in prostate cancer cells, suggesting multiple mechanisms of action that could make it a promising complementary treatment alongside conventional therapies for advanced metastatic prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artesunate Inhibits the Growth Behavior of Docetaxel-Resistant Prostate Cancer Cells. Vakhrusheva, O., Erb, HHH., Bräunig, V., et al.[2022]

In a retrospective study of 15 prostate cancer patients treated with high-dose oral artemisinin, 40% of those with prior radical prostatectomy and 50% of those without prior treatment showed improved PSA kinetics, suggesting potential efficacy in managing prostate cancer.

The treatment was well-tolerated with no reported adverse effects, indicating that artemisinin may be a safe option for patients, although further research in larger controlled trials is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Case Series of Artemisinin for Prostate Cancer in a Naturopathic Practice. Yarnell, E.[2022]

Artesunate (AS) combined with bicalutamide (Bic) effectively reduces the growth of castrate-resistant prostate cancer cells and overcomes resistance to androgen receptor antagonists, as shown in both cell studies and preclinical mouse models.

In a study involving 28 mice, the AS and Bic combination led to significant tumor regression and reduced metastases in lungs and bones, suggesting a promising new treatment strategy for metastatic castration-resistant prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting NF-kappa B Signaling by Artesunate Restores Sensitivity of Castrate-Resistant Prostate Cancer Cells to Antiandrogens. Nunes, JJ., Pandey, SK., Yadav, A., et al.[2022]

Artesunate (ART) significantly induces cell cycle arrest in the G(2)/M phase of prostate cancer PC-3 cells, suggesting it may hinder cancer cell proliferation.

Treatment with ART also leads to a notable decrease in prostate-specific antigen (PSA) levels, indicating potential effectiveness in reducing tumor markers associated with prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Artesunate induces prostate cancer cell line PC-3 differentiation and cell cycle arrest]. Huang, XF., Yuan, D., Zhang, CC., et al.[2018]

Artemilavanin F, a newly discovered compound from Artemisia lavandulaefolia, showed significant inhibitory effects on PANC-1 pancreatic cancer cells, with an IC50 value of 9.69 μM, indicating its potential as an effective treatment.

The compound works by inducing G2/M cell cycle arrest and apoptosis in cancer cells, while also suppressing cancer stem cell markers and preventing metastasis through downregulation of epithelial-mesenchymal transition markers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eudesmane-type sesquiterpenoids from the aerial parts of Artemisia lavandulaefolia and their anti-pancreatic cancer activities. Ding, LF., Hu, GX., Liu, YY., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05478239

NCT05478239 | ArtemiCoffee in Patients With Rising PSA It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.TPS350

Phase II trial of ArtemiCoffee for men with biochemical ... An open-label, single center, phase II study targets men with BCR PC following primary definitive local therapy and a PSA doubling time > 10 months.

3. withpower.com withpower.com/trial/phase-2-prostate-cancer-10-2022-08dbb

ArtemiCoffee for Prostate Cancer This trial is testing decaf coffee made from the Artemisia annua plant in patients whose prostate cancer markers are rising after initial treatment.

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-07361

ArtemiCoffee for the Treatment of Biochemical Recurrence ... This phase II trial tests whether Artemisia annua decaffeinated coffee can lower prostate specific antigen (PSA) level in men with biochemical recurrence of ...

5. clinicaltrials.phentrials.com clinicaltrials.phentrials.com/clinical-trials/artemicoffee-in-patients-with-rising-psa/

ArtemiCoffee in Patients With Rising PSA It is hypothesized that Artemisia annua (Aa) coffee has the potential to decrease rising PSA among patients with biochemical recurrence of prostate cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10888123/

Anticancer Effect by Combined Treatment of Artemisia ... In this study, we examined how the anticancer effect of DTX is regulated by polyphenols extracted from Korean Artemisia annua L. (pKAL) in DU145 ...

7. connect.mayoclinic.org connect.mayoclinic.org/discussion/artemisia-annua-coffee/

Artemisia annua coffee This trial aims to determine if Artemisia annua decaffeinated coffee can lower prostate-specific antigen (PSA) levels in men with biochemical recurrence of ...