Phase 3 IMPACT Trial
The PROVENGE IMPACT Trial Design
The pivotal IMPACT trial was a Phase 3, randomized, double-blind, multicenter, controlled study in 512 men with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (CRPC).1
Primary endpoint—Overall survival
Secondary endpoint—Time to objective disease progression
- 64% of patients in the control group, following progression, crossed over to a nonrandomized, open-label protocol to receive an investigational autologous immunotherapy made from cryopreserved cells.1
- Treatment in the open-label protocol was at the physician's discretion.
Learn More About Phase 3 IMPACT Trial Results
Next: Survival Benefit
References
- Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castrate-resistant prostate cancer. N Engl J Med. 2010;363(5):411-422.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
The most common adverse events (incidence ≥ 15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache.
Please see the Full Prescribing Information.