Treatment may be resumed upon resolution of that toxicity to Grade 2. A patient who experiences a Grade 3 or higher toxicity again will be removed from the study. There are no provisions for dose reductions of radiation therapy or Sipuleucel-T. The maximum delay in treatment will be 14 days. Patients who received at least one infusion of Sipuleucel- T Page 19 of 50 IRB Protocol No. 12367 Version Date: 10/24/2017 Version: 09 w ill not be replaced. Patients who received at least 50 % of anticipated dose of radiation therapy will not be replaced. Patients who received <50 % of anticipated dose of radiation therapy and / or who did not receive any infusions of Sipuleucel-T will be replaced. 7.0 Data and Safety Monitoring, Unanticipated Problems and Adverse Event Reporting 7.1 Definition of Risk Level This is a Risk Level 3 study, as defined in the “City of Hope Data and Safety Monitoring Plan”, http://www.coh.org/dsmc/Pages/forms-and-procedures.aspx because it is a Phase II clinical trial where t he risks are at least balanced by the potential benefit to subjects and the importance of the knowledge that may result. 7.2 Monitoring and Personnel Responsible for Monitoring The Protocol Management Team (PMT) consisting of the PI, Collaborating Investigator, CRA, protocol nurse, and statistician are responsible for monitoring the data and safety of this study, including implementation of any stopping rules for safety and efficacy. Table 1: City of Hope PMT Reporting Timelines for the DSMC Risk Level Phase Standard Reporting Requirement RL 1, RL2, and Compassionate Use Studies No reports required 3 I Ever y 3 months from activation date, as indicated in MIDAS 3 Pilot, Feasibility, II-IV Every 6 months from activation date, as indicated in MIDAS 4 Pilot, Feasibility, I-IV Every 3 months from activation date, as indicated in MIDAS Data and safety will be reported to the COH DSMC using the PMT report and submitted according to the timelines in Table 1 above. Protocol specific data collection will include the following items: summary of accrual, adverse events and treatment-related mortality.