Table 1.

List of ongoing studies of sipuleucel-T identified in Clinicaltrials.gov^*

NCT identifier (Acronym)	Study title	Outcome measures	Sponsor
NCT03686683 (ProVent)	Open-Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer	To assess the efficacy of sipuleucel-T in reducing histopathologic reclassification to a higher Gleason grade in prostate cancer subjects on active surveillance	Dendreon
NCT02463799 (J1522 IRB00056435)	Study of Sipuleucel-T w/ or w/o Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC	Immune responses to treatment with sipuleucel-T (with or without radium-223) measured by peripheral PA2024 T-cell proliferation To evaluate peripheral antigen-specific T-cell proliferation over time To evaluate peripheral antigen-specific T-cell activation to sipuleucel-T over time To evaluate antigen-specific antibody response to sipuleucel-T over time To evaluate sipuleucel-T–induced antigen spread (epitope spread) phenomena To evaluate the sipuleucel-T product immune parameters To investigate safety of combined use of radium-223 and sipuleucel-T (composite measure of both arms) To evaluate time to prostate-specific antigen (PSA) progression To evaluate time to alkaline phosphatase progression To evaluate time to pain progression and first cancer-related opioid use To evaluate time to radiographic or clinical progression To evaluate time to first skeletal related event To evaluate time to first chemotherapy use	Investigator initiated
NCT01818986 (STU 102012-026)	Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)	Time to progression Immune response	Investigator initiated
NCT01804465 (12557 NCI-2014-00318)	Sipuleucel-T With Immediate vs. Delayed Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Blockade for Prostate Cancer	Frequency of observing an immune response to prostatic acid phosphatase and/or PA2024 Frequency of highest grade toxicity PSA response rate Time to PSA progression Radiographic clinical response rate	Investigator initiated
NCT03329742 (IUSCC-06141706081520)	Sipuleucel-T and Low-protein Diet in Patients With Metastatic Castrate-resistant Prostate Cancer	Adherence to diet intervention Feasibility of diet intervention Safety and tolerability of diet intervention combined with sipuleucel-T treatment Rate of immune response Progression-free survival Overall survival	Investigator initiated
NCT01833208 (I 223912 NCI-2013-00633 P30CA016056)	Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T	Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an interferon-gamma enzyme-linked immunosorbent spot assay Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells Quantification of lymphocyte subsets and natural killer cells Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 Cancer-specific survival Change in PSA Overall survival	Investigator initiated
NCT01706458 (CO11816 A534260 SMPH/MEDICINE/MEDICINE*H NCI-2012-02026 2012-0352)	Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer	Number of participants with immune response following treatment Progression-free survival Time to radiographic disease progression Measure PSA doubling time	Investigator initiated

^*Source: clinicaltrials.gov.