Kim Nguyen Chi, MD, highlights patient-reported outcome data from AMPLITUDE

Additional data from the phase 3 AMPLITUDE trial (NCT04497844), presented at the 2025 European Society for Medical Oncology Congress, in Berlin, Germany, offer insights into the tolerability of the regimen of niraparib plus abiraterone acetate (AA; Zytiga) and prednisone (P) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair mutations (HRRm).¹

The AMPLITUDE trial previously demonstrated that the addition of niraparib to AA+P significantly prolonged radiographic progression-free survival in this patient population. In a recent interview with Urology Times®, co-author Kim Nguyen Chi, MD, FRCPC, shared new data from the study on patient-reported outcomes. Chi is the chief medical officer of BC Canada and a professor of medicine at the University of British Columbia in Canada.

The mean baseline FACT-G total score for the niraparib group was 79.7 (standard deviation [SD], 14.9) and was 79.3 (SD, 15.2) for the placebo group. An initial reduction in the health-related quality of life score was observed in the niraparib group, but the score returned to baseline around cycle 5. The overall least squares mean change from baseline for FACT-G total score was 0.02 for the niraparib group vs 0.77 for the placebo group (P = .289).

Mean baseline total FACT-P score was 113.3 (SD, 20.2) in the nirarparib group vs 112.7 in the placebo group, and overall least squares mean change from baseline was –0.05 (SE, 0.67) for the niraparib group vs 1.22 (SE, 0.67) for the placebo group (P = .181). Similar to the FACT-G scores, the scores between the arms were comparable following a decline in the niraparib group during the first 4 cycles.

Similar trends were observed for the FACT-P physical well-being subscale and the EQ-5D-5L visual analog scale.

REFERENCE

1. Rathkopf DE, Agarwal N, Graff JN, et al. Patient (pt) reported outcomes (PROs) from AMPLITUDE, a randomized placebo-controlled phase III trial of niraparib (NIRA) and abiraterone acetate (AA) plus prednisone (P) in metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair mutations (HRRm). Presented at: 2025 European Society for Medical Oncology Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA91. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA91.html.pdf