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
Categories (click each to see list of all clinical trials associated with that category): GU (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Teply, Benjamin
Contact Information:
Natasha Willms
nwillms@nebraskamed.com
Eligibility: https://clinicaltrials.gov/study/NCT03678025?term=NCT03678025&rank=1
Summary
PRIMARY OBJECTIVES:
I. 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:
I. 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.
II. To compare the rate of symptomatic local progression between the treatment arms.
III. To compare progression-free survival (PFS) between the two treatment arms. IV. To compare rates of progression-free survival between arms for the subsets of patients with and without metastasis directed therapy (MDT) to oligometastatic sites.