You have accessJournal of UrologyProstate Cancer: Advanced (III)1 Apr 2013971 SAFETY AND CHANGES IN LABORATORY PARAMETERS ASSOCIATED WITH SIPULEUCEL-T IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: PHASE 2 PROACT STUDY Thomas Gardner, Daniel Petrylak, John Corman, Simon Hall, Ralph Weinstein, Robert Sims, Todd DeVries, and Celestia Higano Thomas GardnerThomas Gardner Indianapolis, IN More articles by this author , Daniel PetrylakDaniel Petrylak New York, NY More articles by this author , John CormanJohn Corman Seattle, WA More articles by this author , Simon HallSimon Hall New York, NY More articles by this author , Ralph WeinsteinRalph Weinstein Portland, OR More articles by this author , Robert SimsRobert Sims Seattle, WA More articles by this author , Todd DeVriesTodd DeVries Seattle, WA More articles by this author , and Celestia HiganoCelestia Higano Seattle, WA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.552AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Sipuleucel-T is an autologous cellular immunotherapy for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). Sipuleucel-T prepared using the FDA-approved concentration of 10μg/mL PA2024 (PAP-GM-CSF antigen) stimulates immune responses and prolongs overall survival (OS). ProACT (P07-2; NCT00715078) is an ongoing phase 2 study to evaluate immune responses and OS of sipuleucel-T when manufactured using three different concentrations (2, 5 or 10μg/mL) of PA2024. Here we report the preliminary safety analysis and changes in laboratory parameters. METHODS Patients (pts) with asymptomatic or minimally symptomatic mCRPC received sipuleucel-T manufactured using 2, 5 or 10μg/mL PA2024 for a total of 3 infusions with 2-week intervals. Adverse events (AEs) were recorded continuously and laboratory samples for assessment were taken 2, 4 and 6 months (mos) after the first infusion. RESULTS 120 pts were included in the safety analysis (2μg/mL, n=40; 5μg/mL, n=40; 10μg/mL, n=40). Baseline characteristics were balanced across the arms. The most common AEs (occurring in >20% of pts in the total population) were fatigue (44.2%), back pain (30.8%), nausea (30.8%), arthralgia (25.8%) and chills (25.8%), with a consistent incidence of these AEs across treatment arms. AEs occurring within 1 day of infusion (in >20% of pts in the total population) included fatigue (23.3%) and chills (20.8%). Treatment-related serious AEs occurred in 4 pts (3.3%), with fatigue (n=3) and dehydration (n=2) the only events occurring in more than 1 pt. Globulin protein levels increased significantly (p<0.05) from baseline at all time points in the 5μg/mL and 10μg/mL arms and at 2 mos in the 2μg/mL arm. Significant increases in eosinophil counts from baseline were observed at 2 mos in the 5μg/mL and 10μg/mL arms (p<0.05). There was no significant difference between treatment arms in immune responder frequencies (any immune response at any time point). CONCLUSIONS Increases in globulin protein and transient increases in eosinophil counts are consistent with previous studies, which showed that these changes in laboratory parameters positively correlate with immune response and OS, respectively, and thus may be surrogates for immune response. Furthermore, these data suggest that sipuleucel-T manufactured using 3 different concentrations of PA2024 has an acceptable safety profile. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e399 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thomas Gardner Indianapolis, IN More articles by this author Daniel Petrylak New York, NY More articles by this author John Corman Seattle, WA More articles by this author Simon Hall New York, NY More articles by this author Ralph Weinstein Portland, OR More articles by this author Robert Sims Seattle, WA More articles by this author Todd DeVries Seattle, WA More articles by this author Celestia Higano Seattle, WA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...