Return to Clinical Trials Search Results

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Primary Objective Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with SABR plus placebo vs. SABR plus relugolix. Secondary Objectives Compare conventional or PET-based radiological progression-free survival (prPFS) between treatment arms. Compare patient-reported sexual and hormonal quality of life as assessed by corresponding EPIC-26 domains between treatment arms. Compare other measures of quality of life obtained from the EQ5D-5L, EORTC QLQ-30, PROMIS Fatigue instruments between the two treatment arms. Compare time to salvage therapy and time to castration-resistance between treatment arms. Compare local progression (SABR-targeted lesion), biochemical progression, distant metastases, prostate cancer-specific mortality, metastasis-free survival, and overall survival between treatment arms. Determine adverse events rates and compare rates between the two treatment arms. Exploratory Objectives Evaluate genomic and peripheral tissue and blood markers of treatment response.

Primary Objective Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with SABR plus placebo vs. SABR plus relugolix. Secondary Objectives Compare conventional or PET-based radiological progression-free survival (prPFS) between treatment arms. Compare patient-reported sexual and hormonal quality of life as assessed by corresponding EPIC-26 domains between treatment arms. Compare other measures of quality of life obtained from the EQ5D-5L, EORTC QLQ-30, PROMIS Fatigue instruments between the two treatment arms. Compare time to salvage therapy and time to castration-resistance between treatment arms. Compare local progression (SABR-targeted lesion), biochemical progression, distant metastases, prostate cancer-specific mortality, metastasis-free survival, and overall survival between treatment arms. Determine adverse events rates and compare rates between the two treatment arms. Exploratory Objectives Evaluate genomic and peripheral tissue and blood markers of treatment response.