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

Inclusion Criteria:

• Histologically documented prostate cancer
• Prior primary therapy for prostate cancer
• Rising prostate specific antigen (PSA) with a PSA doubling time (PSADT) of ≤ 12 months
• Non-metastatic disease with ECOG performance status ≤ 1
• 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 (roundtrip 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 more than 6 months duration in total
• Disease-free and off treatment for 10 years for other stage III/IV malignancies or 5 years for other stage I/II malignancies
• Prior experimental immunotherapy 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