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Clinical Trial Details

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Brief Title Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance
Official Title A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer
Principal Investigator Szmulewitz, Russell
Brief Summary Asymptomatic men with progressive metastatic CRPC post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels [i.e. Bipolar Androgen Therapy (BAT)] will improve primary and secondary objectives vs. enzalutamide as standard therapy.
Gender Male
Ages 18 Years
Enrollment 180
Accepts Healthy Volunteers No
Lead Sponsor Sidney Kimmel Comprehensive Cancer CenterOther
Collaborator United States Department of DefenseU.S. Fed
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Castration Resistant Metastatic Prostate Cancer
Detail for Health Professional (on clinicaltrials.gov)
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