Evaluating the effectiveness and safety of apalutamide plus abiraterone and prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

This study evaluated the effectiveness and safety of apalutamide (Erleada) in combination with abiraterone acetate (Zytiga) plus prednisone (Deltasone) (AAP) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). The data showed that apalutamide plus AAP combination significantly improved survival without progression or cancer worsening in these patients.

mCRPC is an aggressive form of PC that has spread beyond the prostate gland and is no longer responsive to hormonal therapy such as androgen-deprivation therapy (ADT). ADT reduces the production of androgens (male sex hormones such as testosterone). Reducing these androgens stops cancer cell growth.

Abiraterone acetate (AA) is a medication that blocks the effect of male sex hormones. Therefore, it slows down prostate cancer growth. Prednisone (P) is a corticosteroid usually given in combination with AA to treat mCRPC. Apalutamide is an anti-androgen medication. It blocks testosterone from reaching PC cells. AAP is approved for the treatment of patients with mCRPC. However, many patients become resistant to this treatment. It is important to evaluate if adding apalutamide to AAP improves the outcomes of patients with mCRPC. 

This study involved 982 men with mCRPC. Patients were randomly assigned into 2 groups. Group 1 included 492 patients who received apalutamide plus AAP. Group 2 included 490 patients who received AAP and a placebo. Patients were followed up for an average of 25.7 months.

The average survival without cancer worsening was significantly longer for group 1 (22.6 months) compared to group 2 (16.6 months). Patients in group 1 were 31% more likely to survive without cancer worsening than patients in group 2.

The average overall survival was slightly higher for group 1 (36.2 months) compared to group 2 (33.7 months).

40% of patients in group 1 experienced severe side effects compared to 37% of the patients in group 2. The most common side effect was an increase in blood pressure. The overall health-related quality of life was not worsened in group 1 compared to group 2. 

This study concluded that apalutamide plus AAP significantly improved survival without cancer worsening in patients with mCRPC.

This study was funded by Janssen Research & Development, the manufacturers of apalutamide.