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Phase IIIInterventional

S1802-VA:Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer)

Protocol: STUDY00009922NCT: NCT03678025

Overview

Primary Objective:

  • To compare overall survival in metastatic prostate cancer patients who are randomized to standard systemic therapy (SST) plus definitive treatment of the primary tumor versus standard systemic therapy alone.

Secondary Objectives:

  • To compare overall survival in metastatic prostate cancer patients who received SST plus surgical excision of the primary tumor versus SST alone in the subset who specify the surgical intent stratification factor.

  • To compare the rate of symptomatic local progression between the treatment arms. (Refer to Section 10.0 for definitions of symptomatic local progression.)

  • To compare progression-free survival (PFS) between the two treatment arms.

  • To compare rates of progression-free survival between arms for the subsets of patients with and without