Evaluating the effectiveness and safety of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer.

This study evaluated the effectiveness and safety of rezvilutamide (Ariane) versus bicalutamide (Casodex) in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The data showed that rezvilutamide in combination with ADT significantly improved the survival outcomes compared with bicalutamide plus ADT with manageable side effects in these patients.

Patients with mHSPC have prostate cancer that has spread beyond the prostate gland and is 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 prevents cancer cell growth.

Both rezvilutamide and bicalutamide are anti-androgen medications that block testosterone from reaching PC cells. Bicalutamide in combination with ADT is a standard treatment in men with mHSPC. Rezvilutamide is a newer medication. Therefore, the effectiveness and safety of rezvilutamide plus ADT versus bicalutamide plus ADT for the treatment of patients with mHSPC are still unknown.

This study involved 654 men with mHSPC. Patients were randomly assigned into 2 groups. Group 1 included 326 patients who received rezvilutamide in combination with ADT. Group 2 included 328 patients who received bicalutamide in combination with ADT. The average follow-up time was 29.3 months.

The average overall survival was not reached in either group (exceeded the average follow-up period). Patients in group 1 were 42% more likely to survive than patients in group 2. After 2 years, 81.6% of the patients in group 1 were alive compared to 70.3% of the patients in group 2.

The average survival without cancer worsening was not reached in group 1 (exceeded the average follow-up period) compared to 25.1 months in group 2. Patients in group 1 were 56% more likely to survive without cancer worsening than patients in group 2. After 2 years, 72.3% of the patients in group 1 were alive without cancer worsening compared to 50% of the patients in group 2.

The rate of serious side effects was similar between the 2 groups (28% in group 1 versus 21% in group 2). The most common side effects in both groups were high blood pressure, increased weight, and low red blood cell counts.

This study showed that rezvilutamide in combination with ADT significantly improved the survival outcomes of patients with mHSPC compared with bicalutamide plus ADT, with manageable side effects.

This study was funded by Jiangsu Hengrui Pharmaceuticals, the manufacturer of rezvilutamide. This study did not include patients who received chemotherapy. The patients knew which treatment they were getting, which might affect the conclusions.