The AMPLITUDE study (NCT04497844) is being carried out to evaluate Akeega, a dual-action tablet that combines the PARP inhibitor niraparib with abiraterone acetate, in conjunction with prednisone.
This combination is being compared against abiraterone acetate and prednisone alone in the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) who have deleterious germline or somatic homologous recombination repair (HRR) gene mutations. The trial is expected to conclude in November 2024.
The trial has enrolled 696 patients across 387 sites worldwide. The primary endpoint is radiographic progression-free survival (rPFS). The treatment arm receives Akeega, while the active comparator arm receives abiraterone acetate plus prednisone.
In the Phase III MAGNITUDE trial, BRCA-positive patients who received Akeega plus prednisone experienced a statistically significant 47% risk reduction in rPFS. However, patients without BRCA mutations did not see as strong a benefit in the study.
The US Food and Drug Administration (FDA) has approved the combination therapy for treating adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) as detected by an FDA-approved test.
This trial wants to move PARP inhibitor to early stages of the disease.