Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: GTx-758 1000mg; Lupron Depot; GTx-758 2000mg
Intervention description: comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension; comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension; comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
Intervention MeSH terms: Leuprolide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: Male
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. be between age 45 and 80 years of age

          2. be able to communicate effectively with study personnel

          3. ECOG is < or = 2

          4. screening serum total testosterone> or = 150ng/dL

          5. have prostate cancer, confirmed by pathology report

          6. have not been treated with androgen deprivation therapy(chemical or surgical

          7. have a clinical indication for the initiation of androgen deprivation therapy

          8. give written informed consent prior to any study specific procedures

          9. subject must agree to use acceptable methods of contraception

        Exclusion Criteria:

          1. known hypersensitivity or allergy to estrogen or estrogen like drugs

          2. 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

          3. history of abnormal blood clotting,Factor V Leiden clotting disorder, thrombotic
             disease

          4. have ALT or AST above 2 times the upper normal limit

          5. have alkaline phosphatase greater than 3 times UNL and/or bilirubin levels above
             2mg/dL at baseline

          6. patients cannot have brain or spinal cord metastases

          7. patients cannot have or be at risk for spinal cord compression from bone metastases

          8. received an investigational drug within a period of 90 days prior to enrollment in the
             study

          9. received the study medication previously

         10. currently taking testosterone, testosterone-like agents, or antiandrogens including
             5-alpha reductase inhibitors within 4 weeks of randomization

         11. currently taking Saw Palmetto or PC-SPES (the subject may be considered for
             randomization after a 4 week washout period prior to randomization)

         12. have taken diethylstilbestrol or other estrogen products within the previous 12 months
             prior to randomization

         13. have taken body building or fertility supplements within 4 weeks of admission into the
             study (steroids and steroid like supplements)

         14. 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

         15. 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.