Although a clear progression of “non-target” lesions only is exceptional, the opinion of the treating physician should prevail in such circumstances, and the progression status should be confirmed at a later time by the review panel (or Principal Investigator). 5.3.5.3 Clinical Disease Progression The need for palliative radiotherapy for cancer related pain The need for chemotherapy or other change in therapy based on increased cancer related symptoms Worsening ECOG PS to a PS of 3 or 4 based on cancer (not treatment) related symptoms Clinical disease progression can also be determined based on the clinical discretion of the investigator 5.3.5.4 Evaluation of Best Overall Response The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. For Patients with Measurable Disease (i.e., Target Disease) Target LesionsNon-Target LesionsNew LesionsOverall ResponseBest Overall Response when Confirmation is Required* CR CR No CR >4 wks. Confirmation** CR Non- CR/Non-PDNo PR CR Not evaluatedNo PR PR Non- CR/Non- PD/not evaluatedNo PR>4 wks. Confirmation** SD Non- CR/Non- PD/not evaluatedNo SD Documented at least once >4 wks. from baseline** PD Any Yes or NoPDno prior SD, PR or CR 47 Short Title: Enzalutamide Vaccine in mCRPC Version Date: 03/29/2022 Target LesionsNon-Target LesionsNew LesionsOverall ResponseBest Overall Response when Confirmation is Required* Any PD*** Yes or NoPD Any Any Yes PD * See RECIST 1.1 manuscript for further details on what is evidence of a new lesion. ** Only for non-randomized trials with response as primary endpoint.