Approved & Available
FDA approved 2010 for asymptomatic or minimally symptomatic metastatic CRPC.
Provenge (Sipuleucel-T)
Also known as: APC8015 · Autologous Activated Cellular Immunotherapy · dendritic cell prostate vaccine
Provenge is the first FDA-approved therapeutic cancer vaccine in history, approved in 2010. It uses the patient's own immune cells (antigen-presenting cells) collected from blood, activated ex vivo with a PAP-GM-CSF fusion protein to target prostatic acid phosphatase (an antigen overexpressed on prostate cancer cells), and then reinfused. The IMPACT Phase 3 trial showed a 4.1-month improvement in median overall survival (25.8 vs 21.7 months) in men with metastatic castration-resistant prostate cancer — without impacting PSA or progression-free survival, a pattern now understood as the immune response taking months to manifest. Despite approval, uptake was limited by the ~$93,000 price, manufacturing complexity, and the modest survival benefit. However, it validated the proof-of-concept for therapeutic cancer vaccination.
What It Targets
Target Antigen
Prostatic Acid Phosphatase (PAP) fused to GM-CSF
Cancers Targeted
How It Works
Leukapheresis (blood draw) → antigen-presenting cells (monocytes, dendritic cell precursors) are isolated → cultured with PAP-GM-CSF fusion protein for 36–44 hours → cells are activated and loaded with PAP antigen → reinfused into the patient IV → primes T cells to recognise PAP-expressing prostate cancer cells → three cycles at 2-week intervals. GM-CSF acts as a molecular adjuvant stimulating dendritic cell maturation.
Key Trial Results
- IMPACT trial (n=512): 4.1-month improvement in median overall survival (25.8 vs 21.7 months), HR 0.78 (p=0.032)
- 36-month survival: 31.7% vs 23% — meaningful separation in long-term survivors
- No difference in PSA or progression-free survival — immune-mediated benefit lags 6 months before manifesting
- FDA approved April 2010 — first cellular immunotherapy ever approved for any cancer
- Real-world registry: consistent with trial data in mCRPC patients
- Combinability studies with checkpoint inhibitors ongoing (anti-PD-1 may amplify response)
Regulatory Status & Availability
Approval Status
FDA approved 2010 for asymptomatic or minimally symptomatic metastatic CRPC.
Estimated Availability
Available now in the US for eligible prostate cancer patients
Important Considerations
- For metastatic castration-resistant prostate cancer only — not for hormone-sensitive or localised disease
- Extremely expensive (~$90,000–$100,000 for 3-infusion course); insurance coverage variable
- Logistics: 3 leukapheresis sessions + 3 infusion sessions required at accredited centres
- Benefit is a survival improvement, not a cure — for patients with limited remaining options alongside docetaxel
- Manufacturing turnaround is 2–3 days; temperature-sensitive logistics
- Market withdrawn in some countries due to commercial difficulties — US availability limited by centre accreditation
Research References
iOnco provides this information for educational purposes only. Cancer vaccine availability, trial eligibility, and access pathways change frequently. Always discuss vaccination decisions and clinical trial participation with your oncologist or healthcare provider.