Overview
- The randomized, double-blind AMPLITUDE trial enrolled 696 men across 32 countries and found niraparib plus abiraterone acetate and prednisone cut radiographic progression risk by 37% versus standard care.
- Patients with BRCA1/BRCA2 alterations saw a 48% reduction in progression risk, reinforcing calls for broader genomic testing to identify homologous recombination repair gene changes.
- Time to clinically meaningful symptom worsening roughly doubled on the combination, with notable worsening in 16% versus 34% on placebo.
- Safety signals included more anemia and hypertension, a 25% transfusion rate, and higher treatment-related deaths with niraparib (14 vs 7).
- Overall survival showed a trend favoring the combination but remains immature, and UK regulators have not approved niraparib for prostate cancer as NICE awaits further data.