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A Phase I Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Docetaxel in Castration-resistant Prostate Cancer
Selenium, in the form of inorganic Sodium Selenite, may be useful for treating existing prostate cancer. This idea is based on data from our laboratory showing that 1) prostate cancer cells are more sensitive to Selenium (Sodium Selenite)-induced apoptosis than normal prostate epithelial cells, 2) Selenite induces significant growth inhibition of well established prostate cancer tumors in mice at doses that have no detectable toxicity, and 3) Selenite disrupts AR signaling, and that the inhibition of AR expression and activity by Selenite occurs via a redox mechanism involving GSH, superoxide, and Sp1. Altogether, these findings suggest that Selenium may be useful in a variety of potential indications in the natural history of prostate cancer, including both hormone sensitive and castrate resistant prostate cancer, as a single agent, or in combination with radiation, chemotherapy or conventional hormone therapy. Selenite is a potential novel inhibitor of AR expression and function in prostate cancer.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University School of Medicine
Stanford, California, United States
Start Date
April 1, 2010
Primary Completion Date
October 1, 2012
Completion Date
October 1, 2012
Last Updated
March 15, 2017
2
ACTUAL participants
Docetaxel
DRUG
Biosyn
DRUG
Prednisone
DRUG
Lead Sponsor
Sandy Srinivas
NCT04550494
NCT05691465
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