A Randomized, Open-Label, Phase 2 Trial Examining the Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men With Non-metastatic Prostate Cancer and a Rising Serum Prostate Specific Antigen After Primary Therapy

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