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Brief Title: Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
Official Title: Phase II, Open Label, Dose Finding Study of the Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer Compared to a Luteinizing Hormone Releasing Hormone Agonist
Study ID: NCT01326312
Brief Summary: The purpose of this study is to determine whether GTx 758 is effective in achieving and maintaining castrate testosterone levels in men with advanced prostate cancer.
Detailed Description: Prostate cancer is one of the most frequently diagnosed noncutaneous cancers among men in the US and is the second most common cause of cancer deaths. Patients with advanced prostate cancer undergo androgen deprivation therapy (ADT), by either LHRH agonists, LHRH antagonists, DES and other nonselective estrogens, or by bilateral orchiectomy. ADT by LHRH agonists, LHRH antagonists, or bilateral orchiectomy not only reduces testosterone, but also substantially lowers estrogen levels as estrogen is derived from the aromatization of testosterone. ADT-induced estrogen deficiency causes significant side effects which include hot flushes, gynecomastia, bone loss, decreases in bone quality and strength, osteoporosis and life-threatening fractures, adverse lipid changes, increase in body fat composition, and higher cardiovascular disease and myocardial infarction, and depression and other mood changes. GTx-758 is a nonsteroidal selective ER agonist that suppresses LH secretion by the pituitary by feedback inhibition of the hypothalamic-pituitary-gonadal axis to induce castrate levels of testosterone. However, because it is a selective ER agonist, GTx-758 may maintain bone, does not induce hot flushes, avoids adverse lipid changes and body fat composition changes, and does not have the acute testosterone surge that are associated with other forms of ADT.
Minimum Age: 45 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
GTx Investigative Site, Phoenix, Arizona, United States
GTx Investigative Site, La Mesa, California, United States
GTx Investigative Site, Los Angeles, California, United States
GTx Investigative Site, San Bernardino, California, United States
GTx Investigative Site, Middlebury, Connecticut, United States
GTx Investigative Site, Aventura, Florida, United States
GTx Investigative Site, Daytona Beach, Florida, United States
GTx Investigative Site, Wellington, Florida, United States
GTx Investigative Site, Marietta, Georgia, United States
GTx Investigative Site, Springfield, Illinois, United States
GTx Investigative Site, Fort Wayne, Indiana, United States
GTx Investigative Site, Indianapolis, Indiana, United States
GTx Investigative Site, Jeffersonville, Indiana, United States
GTx Investigative Site, Annapolis, Maryland, United States
GTx Investigative Site, Baltimore, Maryland, United States
GTx Investigative Site, Brick, New Jersey, United States
GTx Investigative Site, Lawrenceville, New Jersey, United States
GTx Investigative Site, Albuquerque, New Mexico, United States
GTx Investigative Site, Albany, New York, United States
GTx Investigative Site, Garden City, New York, United States
GTx Investigative Site, New York, New York, United States
GTx Investigative Site, Oneida, New York, United States
GTx Investigative Site, Syracuse, New York, United States
GTx Investigative Site, Chapel Hill, North Carolina, United States
GTx Investigative Site, Raleigh, North Carolina, United States
GTx Investigative Site, Cincinnati, Ohio, United States
GTx Investigative Site, Columbus, Ohio, United States
GTx Investigative Site, Bala-Cynwyd, Pennsylvania, United States
GTx Investigative Site, Lancaster, Pennsylvania, United States
GTx Investigative Site, Pittsburgh, Pennsylvania, United States
GTx Investigative Site, Myrtle Beach, South Carolina, United States
GTx Investigative Site, Memphis, Tennessee, United States
GTx Investigative Site, Nashville, Tennessee, United States
GTx Investigative Site, Arlington, Texas, United States
GTx Investigative Site, Houston, Texas, United States
GTx Investigative Site, San Antonio, Texas, United States
Name: Mitchell Steiner, MD
Affiliation: GTx
Role: STUDY_DIRECTOR