GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: GTx-758
Intervention description: two GTx 758 tablets per day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Double
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: castrate resistant

Summary:

      The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific
      antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on
      androgen deprivation therapy (Serum PSA response and Serum PSA progression)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be over 18 years of age

          2. Be able to communicate effectively with the study personnel

          3. Have histologically confirmed prostate cancer

          4. ECOG performance status of 0 to 2

          5. Have been treated with ADT(chemical or surgical) for at least 6 months

          6. Have castrate level of serum total testosterone (<50 ng/dL)

          7. Have a history of serum PSA response after initiation of ADT, serum PSA response is at
             least a 90% reduction in serum PSA to <10 ng/mL OR undetectable level of serum PSA
             (less tan or =0.2 ng/mL)

          8. Have rising serum PSA on two successive assessments at least 2 weeks apart and serum
             PSA levels ≥ 2 ng/mL or 2ng/mL and a 25% increase over the nadir after the initiation
             of ADT

          9. Be continued on androgen deprivation therapy throughout this study

         10. Give written informed consent prior to any study specific procedures

         11. Subjects must agree to use acceptable methods of contraception:

        oIf their female partners are pregnant or lactating acceptable methods of contraception
        from the time of the first administration of study medication until 3 months following
        administration of the last dose of study medication must be used. Acceptable methods are:
        Condom used with spermicidal foam/gel/film/cream/suppository. If the subject has undergone
        surgical sterilization (vasectomy with documentation of azospermia) a condom with
        spermicidal foam/gel/film/cream/suppository should be used. oIf the male subject's partner
        could become pregnant, use acceptable methods of contraception from the time of the first
        administration of study medication until 3 months following administration of the last dose
        of study medication. Acceptable methods of contraception are as follows: Condom with
        spermicidal foam/gel/film/cream/suppository [i.e. barrier method of contraception],
        surgical sterilization (vasectomy with documentation of azospermia) and a barrier method
        {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses
        oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or
        subdermal implants and a barrier method {condom used with spermicidal
        foam/gel/film/cream/suppository}. oIf the female partner has undergone documented tubal
        ligation (female sterilization), a barrier method {condom used with spermicidal
        foam/gel/film/cream/suppository} should also be used. oIf the female partner has undergone
        documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and a
        barrier method {condom with spermicidal foam/gel/film/cream/suppository} should also be
        used.

        Exclusion Criteria:

          1. Known hypersensitivity or allergy to estrogen or estrogen like drugs;

          2. Have symptomatic metastatic prostate cancer

          3. Any disease or condition (medical or surgical) which might compromise the hematologic,
             cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central
             nervous system; or other conditions that may interfere with the absorption,
             distribution, metabolism or excretion of study drug, or would place the subject at
             increased risk;

          4. History of abnormal blood clotting, Factor V Leiden clotting disorder, thrombotic
             disease (venous or arterial thrombotic events such as history of stroke, deep vein
             thrombosis (DVT), and/or pulmonary embolus (PE))

          5. Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris,
             cardiac arrhythmia

          6. The presence of consistently abnormal laboratory values which are considered
             clinically significant. In addition, no subject with liver enzymes (ALT or AST) above
             2 times the ULN, total bilirubin above 2 times the ULN, or serum creatinine above 1.5
             ULN will be admitted to the study

          7. Received an investigational drug within a period of 90 days prior to enrollment in the
             study

          8. Received the study medication previously

          9. Currently taking testosterone, testosterone-like agents, or antiandrogens,including
             5-alpha reductase inhibitors (may be eligible if allow a 6 week washout period after
             stopping antiandrogens);

         10. History of prior treatment of cancer chemotherapy agent (other than hormone therapy)
             or radiopharmaceutical for prostate cancer.

         11. Have taken ketoconazole within the previous 12 months prior to randomization into this
             study

         12. Have taken diethylstilbestrol or other estrogen products, ketoconazole, or abiraterone
             within the previous 12 months prior to randomization into this study

         13. Have taken body building or fertility supplements within 4 weeks of admission into the
             study

         14. Have been previously diagnosed with cancer (other than prostate cancer, superficial
             bladder cancer, or non-melanoma skin cancer).