The addition of niraparib to abiraterone significantly improved progression-free survival in patients with HRR-deficient metastatic prostate cancer. Safety analysis showed higher rates of serious adverse events with the combination therapy, including anemia and hypertension.
Study
|
Randomized, double-blind, placebo-controlled, phase 3 trial [AMPLITUDE] |
| HRR-deficient metastatic castration-sensitive prostate cancer |
| Niraparib+Abiraterone (n=348) vs Placebo+Abiraterone (n=348)
|
Efficacy
|
Radiographic mPFS among pts wit RBCA alterations: NR vs. 26 mos (niraparib vs. placebo) (HR: 0.52 [0.32-0.72]) |
| Radiographic mPFS among HRR-deficient: NR vs 29.5 mos (HR 0.63 [0.49-0.80]) |
| OS among BRCA_altered: HR 0.75 [0.51-1.11] |
| OS among HR-deficient: HR 0.79 [0.59-1.04]
|
Safety
|
Grade >=3 AEs: anemia (29.1% vs 4.6%), hypertension (26.5% vs 18.4%) |
| Treatment-emergent deaths: 14 vs 7 |
| Discontinuation due to AEs: 43.2% vs 10.3%
|
Nat Med. Published online 7 October 2025
http://doi.org/10.1038/s41591-025-03961-8
Reviewed by Ulas D. Bayraktar, MD on Dec 19, 2025
