Authors:
 Jaime O. Herrera-Caceres, Anthony Joshua, Joan Sweet, Joseph Chin, Aaron Hansen, Srikala Sridhar, Robert Hamilton, Eric Winquist, Antonio Finelli, Alexandre Zlotta, Neil Fleshner
 
 
 Affiliations:
 Princess Margaret Cancer Center - University Health Network
 
 
 Abstract Body:
 "Background:
 High-risk prostate cancer (PC) has a significant risk of recurrence when treated with unimodal therapy. The utility of neoadjuvant therapy, prior to RP has yet to be defined. The Princess Margaret Cancer Centres’ ACDC study investigates the application of agents used for castration resistant PC in the neoadjuvant setting by comparing 
 the use of abiraterone(AA)+prednisone(P)+leuprolide(LHRH) with or without cabazitaxel prior to RP in 76 high-risk patients. Herein, we report early results and protocol modifications.
 
 Material and Methods:
 This phase II trial will randomize patients to two treatment arms: Arm A (AA/P + LHRH + cabazitaxel 25 mg/m2 with peg-filgrastim 6 cycles) or Arm B (AA/P + LHRH) for 6 months prior to RP. The primary objective is to compare the pathological complete response (CR) between the treatment arms. We present the RP outcomes and safety data for the first 40 participants.
 
 Results
 Out of 40 randomized participants, 33 completed study procedures and underwent RP. One participant (Arm B) completed study drug treatment, but opted for radiation therapy, while 2 participants (both in Arm B) were discontinued due to hepatoxicity. At RP, 4 participants exhibited CR (2 from each arm) and an additional 11 patients exhibited near CR (less than 5% tumor volume, 8 in Arm A). Table 1 demonstrates patient characteristics, pathologic results and Grade 3 adverse events rates. Of note, 2 patients (both in cabazitaxel arm) developed post-operative thrombo-embolic events post RP and two experienced febrile neutropenia.
 
 Conclusions
 Early findings indicate significant tumor response with 45% of patients exhibiting CR or near CR. Reduction in dosage of Cabazitaxel to 20 mg/m2 as well as need for extended post-operative thromboembolic prophylaxis have been implemented."
 
 
 Funding Acknowledgments:
 Funding for the study has been provided by grant from the Ontario Institute for Cancer Research (OICR). Study drug are generously provided by Janssen, Sanofi, and Amgen.
 
 
 Corresponding Author Email:
 miran.kenk@uhn.ca
 
 
 Conflict of Interest:
 Nothing to Disclose

Preoperative Trial of Neo Adjuvant Abiraterone Plus Or MInus Cabazitaxel: Early Results