Sipuleucel-T therapy may be considered medically necessary in the treatment of asymptomatic or minimally symptomatic, androgen-independent (castration-resistant) metastatic prostate cancer.
Sipuleucel-T therapy is considered investigational in all other situations, including but not limited to, treatment of hormone-responsive prostate cancer, treatment of moderate-to-severe symptomatic metastatic prostate cancer, and treatment of visceral (liver, lung, or brain) metastases.