Mp67-16 surgical outcomes in patients receiving neoadjuvant vaccine therapy (prostvac) prior to radical prostatectomy: a phase ii experience

You have accessJournal of UrologyCME1 Apr 2023MP67-16 SURGICAL OUTCOMES IN PATIENTS RECEIVING NEOADJUVANT VACCINE THERAPY (PROSTVAC) PRIOR TO RADICAL PROSTATECTOMY: A PHASE II EXPERIENCE Zoe Blake, Daniel Nemirovsky, Alexander Kenigsberg, Neil Mendhiratta, Jacob Enders, Michael Rothberg, Daniel Nethala, Baris Turkbey, Bradford Wood, Sandeep Gurram, Howard Parnes, James Gulley, and Peter Pinto Zoe BlakeZoe Blake More articles by this author , Daniel NemirovskyDaniel Nemirovsky More articles by this author , Alexander KenigsbergAlexander Kenigsberg More articles by this author , Neil MendhirattaNeil Mendhiratta More articles by this author , Jacob EndersJacob Enders More articles by this author , Michael RothbergMichael Rothberg More articles by this author , Daniel NethalaDaniel Nethala More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , Bradford WoodBradford Wood More articles by this author , Sandeep GurramSandeep Gurram More articles by this author , Howard ParnesHoward Parnes More articles by this author , James GulleyJames Gulley More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: PROSTVAC is a therapeutic cancer vaccine designed to activate T cells specific against prostate-specific antigen (PSA). Previous trials have shown PROSTVAC to be safe and capable of modulating immune responses in patients with localized prostate cancer (PCa). We aim to examine the surgical safety and feasibility outcomes of patients in a phase II trial (NCT02153918) investigating the neoadjuvant use of this vaccine therapy in patients with localized PCa. METHODS: An open-label, phase II study of neoadjuvant PROSTVAC vaccine enrolled patients with histopathologically confirmed localized PCa who were surgical candidates for radical prostatectomy (RP). Patients received recombinant vaccinia (rV)-PSA(L155)-TRICOM (PROSTVAC) as a priming vaccination, followed by monthly boosts on weeks 5, 9 and 13 with recombinant fowlpox (rF)-PROSTVAC. The boosting schedule was amended mid-trial to weeks 3, 5 and 9 to allow for earlier surgeries. After completing the vaccination series, patients underwent RP at week 10. Final follow-up safety evaluation was performed 12–15 months postoperatively. RESULTS: Between 2014-2016, 26 of 27 enrolled patients went on to receive RP. On pre-RP biopsy, 12/26 (46.2%) of patients had Gleason grade group (GG) 1-2, and 14/26 (53.8%) of patients had GG 3-5 (Table 1). Two patients (7.7%) were upgraded, and five (19.2%) downgraded on final pathology. Rates of adverse features at RP are shown in Table 2. The most common adverse event (AE) was a self-limited injection-site reaction (28 events in 18 patients), and no serious AEs or toxicities>grade 2 were attributed to PROSTVAC. However, two grade 3 serious AEs occurred: an infected lymphocele and a thromboembolic event, both attributed to surgery. CONCLUSIONS: PROSTVAC was well tolerated and demonstrated the feasibility of neoadjuvant vaccination strategies for localized PCa. Further studies will be needed to elucidate the effectiveness of this vaccine therapy on short and long-term oncologic outcomes. Source of Funding: NIH intramural research program © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e949 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Zoe Blake More articles by this author Daniel Nemirovsky More articles by this author Alexander Kenigsberg More articles by this author Neil Mendhiratta More articles by this author Jacob Enders More articles by this author Michael Rothberg More articles by this author Daniel Nethala More articles by this author Baris Turkbey More articles by this author Bradford Wood More articles by this author Sandeep Gurram More articles by this author Howard Parnes More articles by this author James Gulley More articles by this author Peter Pinto More articles by this author Expand All Advertisement PDF downloadLoading ...