An Extended Course of Sipuleucel-T Immunotherapy for Treating Patients with Metastatic Castration-resistant Prostate Cancer, EXCITE Trial
This phase I trial tests the safety and side effects of, and patient immune response to, an extended course of sipuleucel-T immunotherapy in treating patients with prostate cancer that has not responded to treatments that lower testosterone levels (castration-resistant) and that has spread from where it first started (primary site) to other places in the body (metastatic). Sipuleucel-T is a type of immunotherapy. It is made from immune system cells collected from a patient with prostate cancer. The cells are treated with a protein that is made by combining a protein found on prostate cancer cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells (a type of immune cell) to kill prostate cancer cells. Currently, the recommended treatment with sipuleucel-T is three doses separated by approximately 2 weeks. In this study, patients receive three doses, but the third dose will be administered 10-12 weeks after the second dose. Sipuleucel-T may help the immune system kill prostate cancer cells. An extended course of sipuleucel-T may be safe, tolerable and/or effective in treating patients with metastatic castration-resistant prostate cancer.