Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 159
Healthy volunteers: no

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.

Arms:
arm 1: GTx-758/Experimental/ nonsteroidal selective ER alpha agonist arm 2: GTx-758/Experimental/ nonsteroidal selective ER alpha agonist arm 3: Luteinizing Hormone Releasing Hormone Agonist

Interventions: intervention 1: GTx-758 1000mg intervention 2: Lupron Depot intervention 3: GTx-758 2000mg
Intervention descriptions: intervention 1: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension intervention 2: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension intervention 3: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension

Protocol document: