NICE has taken the decision not to recommend enzalutamide for the treatment of high-risk hormone-relapsed non-metastatic prostate cancer.
The decision is based on the results of the Safety and Efficacy Study of Enzalutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER), a double-blind randomised placebo-controlled trial which included 1401 patients with high-risk hormone-relapsed non-metastatic cancer, allocated to either enzalutamide plus ADT (n=933) or placebo plus ADT (n=468). The primary outcome was metastasis-free survival, defined as the time to radiographic evidence of metastasis or death, whichever occurred first. Scans were done every 16 weeks, or sooner if metastatic disease was suspected.
PROSPER found median metastasis-free survival with enzalutamide was 36.6 months compared with 14.7 months for placebo (hazard ratio [HR] 0.29; 95% CI 0.24-0.35; P<0.0001) based on the final analysis.
However, NICE raised a number of concerns in relation to the trial methodology and data on overall survival, including the fact that the study was statistically powered to detect benefit in metastasis-free survival rather than overall survival and did not account for the costs and benefits of subsequent treatments.
With a list price of £97.67 (excluding VAT) per day, NICE concluded the treatment does not qualify as a cost-effective use of NHS resources.
The current recommendation is scheduled for review in May 2022.
