Setback in Prostate Cancer Trial: CAPItello-280 Study for Truqap Discontinued
The Phase III clinical trial CAPItello-280, evaluating a novel treatment combining capivasertib with docetaxel and androgen-deprivation therapy (ADT) for metastatic castration-resistant prostate cancer (mCRPC), has been terminated. This global study enrolled 1,033 adult patients whose mCRPC had progressed despite ADT, comparing the capivasertib combination against docetaxel, ADT, and a placebo. Following a pre-specified interim analysis, the Independent Data Monitoring Committee recommended halting the trial, concluding that the regimen was unlikely to meet its dual primary endpoints of radiographic progression-free survival and overall survival in the overall patient population. The safety profile of capivasertib remained consistent with previous studies, showing no new concerns.
Capivasertib, a first-in-class AKT inhibitor targeting all three AKT isoforms (AKT1/2/3) and administered on an intermittent schedule, is already approved in several regions for specific types of advanced breast cancer, based on successful outcomes from the CAPItello-291 trial. Despite the discontinuation of CAPItello-280, capivasertib continues to be investigated in other Phase III trials for breast and prostate cancers. Data collected from this trial will be used to inform future research efforts, and investigators are committed to ensuring appropriate follow-up care for all enrolled patients.