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Brief Title: Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone
Official Title: A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone
Study ID: NCT04296578
Brief Summary: The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer.
Detailed Description: PRIMARY OBJECTIVE(S): · To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with abiraterone. SECONDARY OBJECTIVE(S): * To assess the safety and tolerability of the combination of sodium selenite and abiraterone in subjects with castration resistant prostate cancer (CRPC) * To assess the pharmacokinetics of sodium selenite * To assess changes in Prostate specific antigen (PSA) To evaluate the anti tumor activity of sodium selenite and abiraterone when given in combination as determined by biochemical progression free survival (PFS) and radiographic PFS.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Name: Susan J Knox
Affiliation: Stanford Universiy
Role: PRINCIPAL_INVESTIGATOR