Androgen-deprivation therapy (ADT) with docetaxel is routine therapy in patients with hormone-naive metastatic prostate cancer. But in patients with non-metastatic prostate cancer, the benefits of ADT-docetaxel therapy are not known. This study aims to evaluate the benefits of ADT plus docetaxel in patients with high-risk prostate cancer with rising prostate-specific antigen (PSA) levels.
This randomized, phase-3, open-label, superiority trial included a total of 254 patients with high-risk prostate cancer with high PSA levels. The patients were randomly assigned in a 1:1 ratio to receive ADT plus docetaxel or ADT alone. The primary outcome of the study was PSA progression-free survival, along with PSA response, radiologic progression-free survival, and overall survival.
At a median follow-up of 30 months, the median PSA progression-free survival was 20.3 months in the ADT-docetaxel group, compared with 19.3 months in the ADT alone group. No significant difference between radiologic progression-free survival was observed. The data for overall survival was not mature and hence was ruled out of the study. Commonly occurring adverse events in the ADT-docetaxel group were neutropenia, febrile neutropenia, and thrombocytopenia.
The research concluded that combined ADT-docetaxel therapy was not superior to ADT alone in improving survival in patients with high-risk prostate cancer with rising PSA levels.