Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer

Inclusion Criteria:

be between age 45 and 80 years of age
be able to communicate effectively with study personnel
ECOG is < or = 2
screening serum total testosterone> or = 150ng/dL
have prostate cancer, confirmed by pathology report
have not been treated with androgen deprivation therapy(chemical or surgical
have a clinical indication for the initiation of androgen deprivation therapy
give written informed consent prior to any study specific procedures
subject must agree to use acceptable methods of contraception

Exclusion Criteria:

known hypersensitivity or allergy to estrogen or estrogen like drugs
a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic disease
have ALT or AST above 2 times the upper normal limit
have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above 2mg/dL at baseline
patients cannot have brain or spinal cord metastases
patients cannot have or be at risk for spinal cord compression from bone metastases
received an investigational drug within a period of 90 days prior to enrollment in the study
received the study medication previously
currently taking testosterone, testosterone-like agents, or antiandrogens including 5-alpha reductase inhibitors within 4 weeks of randomization
currently taking Saw Palmetto or PC-SPES (the subject may be considered for randomization after a 4 week washout period prior to randomization)
have taken diethylstilbestrol or other estrogen products within the previous 12 months prior to randomization
have taken body building or fertility supplements within 4 weeks of admission into the study (steroids and steroid like supplements)
have a history of cancer other than prostate cancer, superficial bladder cancer (with no recurrence in the last 5 years) and/or non-melanoma carcinoma of the skin
QTcB>480 msec, If the first QTcB reading exceeds 480msec two additional ECGs are to be performed separated at least 5 min apart, then take the average of the three QTcB or readings to determine if the subject satisfies the above criteria. If the average QYcB reading is >480 msec then the subject is excluded.