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A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer

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A Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Testosterone cipionate (Primary) ; Testosterone enanthate (Primary) ; Enzalutamide
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Therapeutic Use
  • Acronyms TRANSFORMER

    • Most Recent Events

    • 25 Mar 2021 Results of pooled analysis from TRANSFORMER (NCT02286921; n=15) and RESTORE (NCT02090114; n=45) clinical trials assessing reversing the effects of androgen deprivation therapy in men with metastatic castration resistant prostate cancer, published in the BJU International.
    • 22 Feb 2021 Primary endpoint has not been met. (Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression) as per results published in the journal of clinical oncology.
    • 22 Feb 2021 Results at data cut off (November 2019) assessing efficacy of Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer published in the Journal of Clinical Oncology

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