Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

Inclusion Criteria

• Hormone-sensitive prostate cancer
• Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis
• ECOG performance status ≤ 1
• Histologically documented prostate cancer
• Prior primary therapy for prostate cancer
• Rising PSA with a PSADT of ≤ 12 months
• Testosterone ≥ 200 ng/dL ≤ 28 days of registration
• Adequate hematologic, renal, and liver function
• Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site

Exclusion Criteria

• Requires systemic ongoing immunosuppressive therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
• Prior sipuleucel-T therapy
• Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total
• If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.
• Prior experimental immunotherapy or on an experimental clinical trial within 1 year
• Received denosumab or XRT ≤ 6 months prior to registration
• Received chemotherapy or GM-CSF ≤ 90 days prior to registration
• Received any of the following medications or interventions ≤ 28 days prior to registration
• major surgery requiring general anesthesia
• systemic immunosuppressive therapy
• other prescription treatment for prostate cancer
• Active infection within 1 week of registration
• Likely to receive XRT or surgery for prostate cancer during the study period
• Any medical intervention, any other condition, or any circumstances that could compromise the study.