ArtemiCoffee for Prostate Cancer

Overseen by Zin W. Myint

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Zin W Myint

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

Disqualifiers: Metastatic disease, Cytotoxic chemotherapy, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing decaf coffee made from the Artemisia annua plant in patients whose prostate cancer markers are rising after initial treatment. The goal is to see if this coffee can help lower these markers, as it contains a compound that has shown anti-tumor effects in lab studies.

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.

What data supports the effectiveness of the drug ArtemiCoffee for prostate cancer?

Research shows that artesunate, a component of ArtemiCoffee, can slow the growth of prostate cancer cells and make them more sensitive to other cancer treatments. It works by affecting certain proteins in the cancer cells, leading to reduced tumor growth and increased cancer cell death. ^{1 2 3 4 5}

Is ArtemiCoffee (artesunate) safe for human use?

Artesunate, a component of ArtemiCoffee, has been studied for its effects on prostate cancer cells and has shown potential as a treatment. While these studies focus on its effectiveness, they do not report any specific safety concerns in humans, suggesting it may be generally safe, but more research is needed to confirm this. ^{1 2 3 4 6}

How is the drug ArtemiCoffee different from other prostate cancer treatments?

ArtemiCoffee, which contains artesunate, is unique because it targets androgen receptor pathways and NF-kappa B signaling, potentially restoring sensitivity to antiandrogens in resistant prostate cancer. This approach is different from standard treatments as it combines traditional Chinese medicine with conventional therapy to enhance effectiveness against advanced prostate cancer. ^{1 2 3 4 7}

Research Team

Zin W. Myint

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

My scans show cancer has spread to other parts of my body.

Trial Timeline

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

Treatment Details

Interventions

• ArtemiCoffee (Herbal Therapy)

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.

Participant Groups

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 China for the following indications:

Approved in China as Artesunate for:

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

Who Is Running the Clinical Trial?

Zin W Myint

Lead Sponsor

Trials

3

Recruited

120+

ArtemiLife

Collaborator

Trials

2

Recruited

40+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Artesunate Suppresses the Growth of Prostatic Cancer Cells through Inhibiting Androgen Receptor. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Targeting NF-kappa B Signaling by Artesunate Restores Sensitivity of Castrate-Resistant Prostate Cancer Cells to Antiandrogens. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Artesunate Inhibits the Growth Behavior of Docetaxel-Resistant Prostate Cancer Cells. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Artesunate induces prostate cancer cell line PC-3 differentiation and cell cycle arrest]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Eudesmane-type sesquiterpenoids from the aerial parts of Artemisia lavandulaefolia and their anti-pancreatic cancer activities. [2023]