MP73-12 UNSUSPECTED METASTASES FOUND DURING SCREENING FOR A TRIAL OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced I1 Apr 2015MP73-12 UNSUSPECTED METASTASES FOUND DURING SCREENING FOR A TRIAL OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER E. David Crawford, Jannell R. DePalantino, Philip W. Kantoff, Neal Shore, Willie Underwood, Vijay Reddy, Jim Wang, Suneel Mundle, Zane Yang, Tracy McGowan, and Charles J. Ryan E. David CrawfordE. David Crawford More articles by this author , Jannell R. DePalantinoJannell R. DePalantino More articles by this author , Philip W. KantoffPhilip W. Kantoff More articles by this author , Neal ShoreNeal Shore More articles by this author , Willie UnderwoodWillie Underwood More articles by this author , Vijay ReddyVijay Reddy More articles by this author , Jim WangJim Wang More articles by this author , Suneel MundleSuneel Mundle More articles by this author , Zane YangZane Yang More articles by this author , Tracy McGowanTracy McGowan More articles by this author , and Charles J. RyanCharles J. Ryan More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2688AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Factors associated with rates of progression from non-metastatic to metastatic castration resistant prostate cancer (CRPC) have been described.1,2 We used this information to identify patients at high risk for progression from non-metastatic to metastatic disease (MD) for entry into the IMpact of Abiraterone Acetate in Prostate Specific AntiGEN (IMAAGEN) trial. To report the high rate of unsuspected metastases in asymptomatic patients with CRPC, leading to screen failure. METHODS From April 2011-July 2013, patients were screened for entry into the IMAAGEN trial. Key entry criteria included having CRPC as defined by a rising PSA and a serum T < 50 ng/dL and a PSA ≥ 10 ng/mL or PSA doubling time (PSADT) ≤ 10 months. Primary endpoint of IMAAGEN was proportion of subjects achieving a ≥ 50% reduction in PSA by 6 cycles of treatment. During screening, patients who met entry criteria based on laboratory results underwent imaging studies to screen for local disease progression or MD. RESULTS 298 patients were screened. 167 (56%) patients screen failed. 77 patients had MD, which represents 37% of 208 patients who, by lab results, were eligible for and underwent imaging studies. We will report on the relationship of unsuspected MD to PSA/PSADT entry criteria. CONCLUSIONS A high rate of unsuspected asymptomatic MD was found in this high-risk CRPC patient population (PSA ≥ 10 ng/mL or PSADT ≤ 10months). Our findings build upon other reported data on MD discovered during screening for non-metastatic CRPC trials.3 These findings suggest the need to prospectively define risk factors for development of MD in CRPC to assure timely identification, especially in light of new treatment options. 1Smith MR, Kabbinavar F, Saad F et al. Natural History of Rising Serum Prostate-Specific Antigen in Men with Castrate Nonmetastatic Prostate Cancer. J Clin Oncol 2005;23:2918-2925. 2Smith MR, Cook R, Lee K et al. Disease and Host Characteristics as Predictors of Time to First Bone Metastasis and Death in Men with Progressive Castration-Resistant Nonmetastatic Prostate Cancer. Cancer 2011;117:2077-85. 3Yu EY, Miller K, Nelson J et al. Detection of previously unidentified metastatic disease as a leading cause of screening failure in a phase III trial of zibotentan versus placebo in patients with nonmetastatic, castration resistant prostate cancer. J Urol 2012;188:103-109. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e934 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information E. David Crawford More articles by this author Jannell R. DePalantino More articles by this author Philip W. Kantoff More articles by this author Neal Shore More articles by this author Willie Underwood More articles by this author Vijay Reddy More articles by this author Jim Wang More articles by this author Suneel Mundle More articles by this author Zane Yang More articles by this author Tracy McGowan More articles by this author Charles J. Ryan More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...