Overview

• The Phase III AMPLITUDE trial enrolled 696 men in 32 countries with homologous recombination repair gene alterations and compared niraparib plus abiraterone and prednisone to standard therapy.
• Across all participants, the combination cut the risk of radiographic progression by 37% versus abiraterone and prednisone alone.
• Among patients with BRCA1/BRCA2 mutations, the risk of progression fell by 48% within the HRR-altered cohort.
• Time to symptomatic worsening approximately doubled with niraparib, with notable worsening dropping from 34% to 16%.
• Side effects were more common with the combination, including higher rates of anemia, hypertension and more treatment-related deaths (14 vs 7), while overall survival data remain immature but currently favor niraparib; the drug is not approved for prostate cancer in the UK.