If CR determination depends on a lesion for which the status is unclear by the required tests, it is recommended the residual lesion be investigated with biopsy or fine needle aspirate. 12.0 Data Reporting/Protocol Deviations 12.1 Confidentiality and Storage of Records The original data collection forms will be stored at the originating institution in a secure location. Study data will be entered into an electronic case report form (eCRF) using an encrypted, password protected, secure electronic data capture (EDC) application that meets all HIPAA requirements. When results of this study are reported in medical journals or at meetings, identification of those taking part will not be disclosed. Medical records of subjects will be securely maintained in the strictest confidence, according to current legal requirements. They will be made available for review, as required by the FDA, HHS, or other authorized users such as the NCI, under the guidelines established by the Federal Privacy Act and rules for the protection of human subjects. 12.2 Subject Consent Form The original signed and dated Informed Consent form, HIPAA research authorization form, and the California Experimental Subject’s Bill of Rights will be stored in the research record. At the time of registration, a copy of the original signed and dated consent documents will be available to the patient and another copy will be stored in the medical record. All Institutional, NCI, Federal, and State of California requirements will be fulfilled. Page 37 of 50 IRB Protocol No. 12367 Version Date: 10/24/2017 Version: 09 12.3 Data Collection Forms and Submission Schedule All data will be collected using Medidata EDC electronic case report forms. 12.3.1 Eligibility Checklist The Eligibility Checklist must be completed by a protocol nurse or clinical research associate and signed by an authorized investigator prior to registering the subject. See Section 4.3 for the registration procedure. 12.3.2 Prior Therapy Forms and On-Study Forms Within two weeks of registration, the clinical research associate will submit Prior Therapy Forms and On-Study Forms. 12.3.3 Treatment Forms, Adverse Event Collection Forms, Response/Off Study/Follow Up Forms Within four weeks of completion of therapy, the clinical research associate will submit the Treatment Forms. Completed adverse events collection forms are due within four weeks of as sessments per study calendar (refer to Section 10.0). Response/Follow Up/Off Study Forms are to be submitted within four weeks of the patient being evaluated for response and/or new follow up information is obtained. 12.4 Protocol Deviations 12.5 Deviation Policy This protocol will be conducted in accordance with COH’s “Clinical Research Protocol Deviation Policy” located at http://www.coh.org/dsmc/Documents/Institutional%20Deviation%20Policy.pdf . Deviations from the written protocol that could increase patient risk or alter protocol integrity require prior IRB approval of a single subject exception (SSE) request. In addition, if contractually obligated, the sponsor must also approve the deviation. IRB pre-approved SSE protocol modifications are considered an amendment to the protocol and not a deviation. The submission of a deviation report is not required. Brief interruptions and delays may occasionally be required due to travel delays, airport closure, inclement weather, family responsibilities, security alerts, government holidays, etc. This can also extend to complications of disease or unrelated medical illnesses not related to disease progression. The PI has the discretion to deviate from the protocol when necessary so long as such deviation does not threaten patient safety or protocol scientific integrity. Examples include, but are not limited to: a) dose adjustments based on excessive patient weight; b) alteration in treatment schedule due to non-availability of the research participant for treatment; c) laboratory test results which are slightly outside the protocol requirements but at levels that do not affect participant safety. These instances are considered to be deviations from the protocol. A deviation report will be submitted to the DSMC/IRB within five days. 12.5.1 Reporting of Deviations All deviations will be reported to the COH DSMC within five days. The DSMC will forward to report to the IRB following review. 12.5.2 Resolving Disputes The COH Investigational Drug Service (IDS) cannot release a research agent that would cause a protocol deviation without approval by the PI. Whenever the protocol is ambiguous on a key point, the IDS should rely on the PI to clarify the issue. Page 38 of 50 IRB Protocol No. 12367 Version Date: 10/24/2017 Version: 09 I n situations where there is misperception or dispute regarding a protocol deviation among the persons involved in implementing the protocol, it is the responsibility of the PI to resolve the dispute and the PI may consult with the DSMC chair (or designee) to arrive at resolution. 13.0 Statistical Considerations 13.1 Study Design This is a randomized Phase II study. The primary endpoint is to assess the feasibility, based on percent able or willing to receive all three infusions of Sipuleucel-T immunotherapy, when combining Sipuleucel- T with radiation therapy to a single site of metastasis delivered one week prior to beginning of Sipuleucel- T therapy. The ability to deliver three infusions of Sipuleucel-T, reflects the ability to collect adequate numbers of CD54+ cells for the generation of Sipuleucel-T, and tolerability reflected in the patient’s willingness or ability to receive the three infusions. Secondary endpoints will include toxicity, and measurements of immune responses to PAP, PA2024 and PSA and radiologic responses to therapy with Sipuleucel-T +/- external beam radiation therapy to single metastasis. 13.2 Sample Size Accrual Rate Patients with metastatic castration-resistant prostate cancer who are candidates for Sipuleucel- T immunotherapy. Total Sample size 50.