Clinical Study

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + Tak-700 With Androgen Deprivation Therapy + Bicalutamide In Patients With Newly

Posted Date: May 15, 2019

  • Investigator: Timothy Struve
  • Specialties: Cancer, Oncology, Prostate Cancer
  • Type of Study: Drug

The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide. Efficacy will be determined by overall survival. There are 2 arms in this study. The first arm has the drug TAK-700 and patients will receive 300 mg, PO, twice daily. The second arm has the drug bicalutamide and patients will receive 50 mg, PO, q daily.


Clinical Diagnosis Of Metastatic Prostate Cancer. Serum Testosterone Within Institutional Limits Of Normal. Psa = 2 Ng/Ml Within 90 Days Prior To Initiation Of Androgen Deprivation. Therapy (For Early Induction) Or Prior To Registration (For Late Induction). Dexa Scan Within 2 Years Prior To Registration. Ecg Within 42 Days Prior To Registration And Qtc Interval = 460 Msec. Lvef Within 42 Days Prior To Registration And Within Institutional Limits Of Normal. Adequate Hepatic Function As Evidenced By Bilirubin = 2 X Institutional Upper Limit Of Normal (Uln), Sgot (Ast) And Sgpt (Alt) = 3 X Institutional Uln, Or = 5 X Institutional Uln If Liver Metastases Are Present. Adequate Renal Function As Evidenced By Calculated Creatinine Clearance = 40 Ml/Min. Adequate Hematologic Function As Evidenced By Leukocytes = 3,000/Mcl, Absolute Neutrophil Count (Anc) = 1,500/Mcl, Hemoglobin = 9 G/Dl, And Platelets = 100,000/Mcl. Zubrod Performance Status Of 0 - 2. Zubrod Performance Status 3 Will Be Allowed If From Bone Pain Only. No Known Brain Metastases. No More Than 36 Months Of Prior Neoadjuvant And/Or Adjuvant Hormonal Therapy. No Prior Or Concurrent Therapy With Ketoconazole, Aminoglutethimide Or Abiraterone Acetate, Or Enzalutamide (Mdv3100). No Prior Chemotherapy For Treatment Of Metastatic Prostate Cancer. Prior Chemotherapy In The Neoadjuvant Or Adjuvant Setting Is Allowed. No Concurrent Use Of Lhrh Antagonists (E.G. Degarelix).


Cancer, Prostate, Metastatic Hormone, Newly Diagnosed, S1216

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