A new stud y design schema replace sthe previous one. Section 2.2 Objectives are described separately for Part A and Part B. Section 4.3 Sample size languages are updated according to the protocol amendment. Section 6 Endpoints are described separately for Part A and Part B. Section 8.1 .3 Efficacy anal yses languages are updated to provide more clarity . Section 8.1.4 A PSA -50 response rate anal ysis is added. Section 8.1.5.2 Sunitinib PK section is deleted according to the protocol amendment. Section 10.3 A censoring rule is added for COVID -19 caused missing tumor assessments. Amendment 1 Section 2.1 Editorial updates to match the protocol Section 4.3 Added from the protocol Section 5.3 The definition for the per -protocol population is updated to match the protocol. Section 6 Texts about endpoints are updated to match the protocol Section 8.1.2.1 Texts added to define “treatment related AE” Section 8.1.3 Details added about tumor response anal yses and time to event anal yses. Section 8.1.5.3 A section about PF -06801591 PK analy sis is added to match the protocol Section 10.3 Time to event censoring rules added Protocol B7791001 Statistical Analysis Plan PFIZER CONFIDENTIAL Page 52.INTRODUCTION This document presents the s tatistical anal ysis plan (SAP) for study B77 91001 . The SAP is based on the protocol amendment 7dated November 22, 201 9and protocol amendment 8 dated May 29, 2020.