Capivasertib plus abiraterone showed a significant improvement in radiographic progression-free survival compared to placebo in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer. The treatment was generally well-tolerated with manageable side effects. Overall survival data were immature at the time of analysis.
Study
|
Phase III, randomized, double-blind, placebo-controlled study [CAPItello-281] |
| Men with PTEN-deficient metastatic hormone-sensitive prostate cancer |
| Capivasertib+abiraterone (n=507) vs placebo+abiraterone (n=505), both with prednisone/prednisolone and ADT
|
Efficacy
|
mPFS: 33.2 mos vs 25.7 mos (HR 0.81 [0.66-0.98]) |
| mOS: Not reached vs Not reached (HR 0.90 [0.71-1.15])
|
Safety
|
Diarrhea (51.9% vs 8.0%) |
| Hyperglycemia (38.0% vs 12.9%) |
| Rash (35.4% vs 7.0%) |
| Discontinuation due to diarrhea: 1.0% vs 0% |
| Discontinuation due to rash: 4.8% vs 0.2% |
| Deaths due to AE: 7.2% vs 5.2%
|
Ann Oncol. Published online 2025 Oct 17
http://doi.org/10.1016/j.annonc.2025.10.004
Reviewed by Ulas D. Bayraktar, MD on Nov 14, 2025
