On April 30, 2026, the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee reviewed a new treatment for advanced prostate cancer. The therapy combines capivasertib (Truqap) with abiraterone (Zytiga) for patients whose cancer has a PTEN gene loss. The decision is based on results from a large Phase 3 study called CAPItello-281.
The trial showed that patients receiving the combination treatment had longer disease control, with cancer progression delayed to about 33.2 months compared to 25.7 months with standard treatment. However, there was no clear improvement in overall survival at the time of analysis. Despite more side effects, patients reported that their overall quality of life and daily functioning were not significantly worse.
Side effects were more common with the new combination, including diarrhea, high blood sugar, rash, and anemia. Serious side effects were also higher compared to the placebo group. In the study, patients were randomly assigned to receive either capivasertib or a placebo along with standard hormone therapy, including abiraterone, prednisone, and androgen deprivation therapy.