Highlight
– The AMPLITUDE randomized phase 3 trial (n=696) tested niraparib added to abiraterone acetate plus prednisone (AAP) versus placebo + AAP in HRR‑deficient metastatic castration‑sensitive prostate cancer (mCSPC).
– Primary endpoint met: significant improvement in radiographic progression‑free survival (rPFS) in the BRCA subgroup (HR 0.52; 95% CI 0.37–0.72; median not reached vs 26 months) and in the intention‑to‑treat (ITT) HRR‑altered population (HR 0.63; 95% CI 0.49–0.80).
– Overall survival (OS) data are immature but numerically favored niraparib (HR 0.79; 95% CI 0.59–1.04).
– Toxicity was higher with niraparib: grade 3–4 adverse events 75% vs 59%; anemia (29%) and hypertension (27%) notable; 14 treatment‑emergent deaths in niraparib arm vs 7 with placebo.
