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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the proportion of men who are castrate by Day 60 in those taking GTx 758 compared to those taking Lupron Depot.
60 days
No
Ronald Morton, MD
Study Director
GTx
United States: Food and Drug Administration
G200705
NCT01326312
June 2011
October 2012
Name | Location |
---|---|
GTx Investigative Site | Phoenix, Arizona 85032 |
GTx Investigative Site | La Mesa, California 91942 |
GTx Investigative Site | Middlebury, Connecticut 06762 |
GTx Investigative Site | Aventura, Florida 33180 |
GTx Investigative Site | Marietta, Georgia 30060 |
GTx Investigative Site | Springfield, Illinois 62703 |
GTx Investigative Site | Fort Wayne, Indiana 46825 |
GTx Investigative Site | Annapolis, Maryland 21401 |
GTx Investigative Site | Brick, New Jersey 08724 |
GTx Investigative Site | Albuquerque, New Mexico 87109 |
GTx Investigative Site | Albany, New York 12208 |
GTx Investigative Site | Chapel Hill, North Carolina 27514 |
GTx Investigative Site | Cincinnati, Ohio 45212 |
GTx Investigative Site | Bala Cynwyd, Pennsylvania 19004 |
GTx Investigative Site | Myrtle Beach, South Carolina 29572 |
GTx Investigative Site | Memphis, Tennessee 38117 |
GTx Investigative Site | Arlington, Texas 76017 |