What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those with anti-tumor activity similar to Artemisia annua (Aa) coffee, include hormone therapy, chemotherapy, and herbal supplements. Hormone therapy can cause gynecomastia, hot flashes, decreased libido, and osteoporosis. Chemotherapy agents like docetaxel and cabazitaxel may lead to neuropathy, alopecia, fatigue, and increased infection risk. Herbal supplements are generally well-tolerated but can cause mild side effects such as headache, nausea, and dizziness, with rare severe reactions like hypertension or liver toxicity.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of prostate cancer, focusing on different mechanisms of action. Enzalutamide and apalutamide are second-generation antiandrogens that inhibit androgen receptor signaling, crucial for prostate cancer cell growth. Abiraterone acetate, combined with prednisone, blocks androgen production, another key driver of prostate cancer. These treatments have shown significant efficacy in prolonging survival and delaying disease progression in various stages of prostate cancer. While not directly similar to artesunate, these drugs represent the broader category of anti-tumor agents used in prostate cancer management.

What other types of research exist?

Promising alternatives to Artemisia annua (Aa) coffee for prostate cancer treatment include: 1) Dihydroartemisinin (DHA), which has shown anti-cancer potential in various cancers including breast and ovarian cancer. 2) Saw palmetto, which is commonly used for benign prostatic hypertrophy (BPH) and has been studied for its potential in prostate cancer treatment. 3) Combination therapies involving artemisinin and metformin, which have demonstrated anti-proliferative and apoptotic effects in breast cancer cells and may have potential in prostate cancer.

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Herbal Therapy

ArtemiCoffee for Prostate Cancer

Phase 2

Recruiting

Led By Zin Myint, MD

Research Sponsored by Zin W Myint

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed)

Eastern Cooperative Oncology Group (ECOG) performance status ≤3

Must not have

Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin

Concomitant use of nevirapine, ritonavir, and strong UGT inducers or strong UGT inhibitors such as phenobarbital, rifampin, carbamazepine, diclofenac, imatinib, axitinib, and vandetanib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks (baseline, 3-mos, 6-mos and post-treatment)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, similar herbal supplements may cause digestive upset, allergic reactions, or interact with other medications. Participants will be monitored for any adverse effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am capable of limited self-care and spend less than half of my day in bed.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications like phenobarbital or rifampin.

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

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

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I have received chemotherapy for recurring prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks (baseline, 3-mos, 6-mos and post-treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks (baseline, 3-mos, 6-mos and post-treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks (baseline, 3-mos, 6-mos and post-treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who achieve a 50% decline in PSA levels

Secondary study objectives

Change in PSA velocity and slope from pre-treatment to post-treatment

Percentage change in serial PSA

Percentage change in serial testosterone levels

Other study objectives

Change in plasma concentration of artemisinin and dihydroartemisinin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prostate cancer patientsExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer, such as androgen deprivation therapy (ADT), second-generation antiandrogens (e.g., enzalutamide, apalutamide), and chemotherapy (e.g., docetaxel), work by targeting specific pathways to inhibit cancer growth and progression. ADT reduces androgen levels, which prostate cancer cells rely on for growth. Second-generation antiandrogens block the androgen receptor, preventing cancer cells from using androgens. Chemotherapy, like docetaxel, disrupts cell division, leading to cancer cell death. These mechanisms are crucial for prostate cancer patients as they directly target the cancer's ability to grow and spread, similar to how artesunate in Artemisia annua (Aa) coffee disrupts multiple cancer cell pathways, offering a potential new avenue for treatment.

Artemisinin as an anticancer drug: Recent advances in target profiling and mechanisms of action.Anticancer Effect of AntiMalarial Artemisinin Compounds.