The AMPLITUDE clinical trial (NCT04497844) is evaluating the effectiveness of Akeega, a combination of the PARP inhibitor niraparib and abiraterone acetate, along with prednisone, for treating metastatic castration-sensitive prostate cancer (mCSPC).
This combination therapy is being compared to the use of abiraterone acetate and prednisone alone in patients with specific genetic mutations related to DNA repair. The trial involves 696 patients across numerous global sites and aims to determine if Akeega can improve radiographic progression-free survival (rPFS). Previous studies have shown promising results with Akeega in patients with BRCA mutations, significantly reducing the risk of cancer progression.
The AMPLITUDE trial aims to expand the use of PARP inhibitors to earlier stages of prostate cancer treatment. The trial is expected to conclude in November 2024