Artesunate as a Repurposed Drug for Prostate Cancer
Artesunate is not recommended for prostate cancer treatment, as it lacks guideline support, has no proven survival benefit in clinical trials, and established therapies with demonstrated mortality and quality of life benefits are available.
Guideline Position on Repurposed Drugs
Major oncology societies explicitly recommend against using repurposed medications without proven survival benefit for prostate cancer treatment 1, 2. The European Society for Medical Oncology, American Society of Clinical Oncology, and National Comprehensive Cancer Network do not include artesunate in any treatment algorithms for prostate cancer 1.
Established First-Line Treatments with Proven Survival Benefits
For patients requiring systemic therapy, guideline-recommended options with demonstrated mortality benefits include:
Metastatic Hormone-Sensitive Disease
- ADT plus docetaxel for fit patients with high-volume disease (HR 0.61 for overall survival) 3
- ADT plus abiraterone for high-risk disease per LATITUDE trial 3
- ADT plus enzalutamide (160 mg daily) with strong survival benefits 3
- ADT plus apalutamide (240 mg daily) with improved radiographic progression-free and overall survival 3
Castration-Resistant Disease
- Docetaxel-based chemotherapy remains standard with proven overall survival benefit (HR 0.76) 3
- Abiraterone or enzalutamide for asymptomatic/mildly symptomatic chemotherapy-naïve patients 3, 2
- Radium-223 for bone-predominant symptomatic disease (HR 0.70 for overall survival) 3
- Cabazitaxel after docetaxel failure with survival benefit 3
Why Artesunate Cannot Be Recommended
Lack of Clinical Trial Evidence
While preclinical studies show artesunate inhibits growth of docetaxel-resistant prostate cancer cells through multiple mechanisms including G0/G1 arrest, apoptosis induction, and ferroptosis 4, these are laboratory findings only. No phase III randomized controlled trials have evaluated artesunate's impact on overall survival, prostate cancer-specific mortality, or quality of life in prostate cancer patients 4, 5.
Mechanistic Studies Are Insufficient
Research demonstrates artesunate can restore sensitivity to antiandrogens in castrate-resistant cells by targeting NF-κB signaling and inducing AR degradation 5. Animal studies show tumor regression in xenograft models 5. However, these preclinical findings have not translated into human clinical trials demonstrating survival benefit, which is the mandatory standard for prostate cancer treatment recommendations 1, 2.
Safety Concerns in Cancer Context
While artesunate has established safety as an antimalarial drug 6, 7, its safety profile specifically in cancer patients receiving concurrent standard therapies (docetaxel, novel hormone agents) remains undefined. The cardiovascular toxicity concerns noted with other repurposed agents underscore the need for rigorous clinical trial data 1.
Clinical Decision Algorithm
For any prostate cancer patient, prioritize treatments in this order:
Determine disease stage and risk category using PSA, Gleason score, imaging, and castration status 3
For metastatic hormone-sensitive disease:
For castration-resistant disease:
After progression on first-line therapy:
Critical Pitfalls to Avoid
Do not delay proven therapies to trial unproven repurposed drugs, as this directly compromises survival outcomes 1. The window for effective intervention in metastatic prostate cancer is time-sensitive, particularly in high-volume or rapidly progressing disease 3.
Do not confuse preclinical activity with clinical efficacy. Artesunate's demonstrated activity against cancer cell lines 4, 7 and its ability to sensitize cells to chemotherapy 8 are hypothesis-generating only and do not substitute for phase III trial evidence of survival benefit.
Recognize that "low toxicity" in malaria treatment does not guarantee safety when combined with cytotoxic chemotherapy or novel hormone agents in cancer patients with different comorbidity profiles 1.