Last updated on January 2020

A Study of Apalutamide in Participants With High Risk Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer | Malignant neoplasm of prostate | Recurrent | Early | Prostate Disorders | Prostatic disorder
  • Age: Between 18 - 100 Years
  • Gender: Male

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate
  • Candidate for radical prostatectomy with lymph node dissection as per the investigator
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Contraceptive (birth control) use by men (or female partners of men enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
  • Able to receive androgen deprivation therapy (ADT) for up to 1 year, per the investigator's assessment

Exclusion Criteria:

  • Distant metastasis (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Participants are considered eligible only if the central radiological review confirms clinical stage M0
  • Prior treatment with antiandrogen
  • History of pelvic radiation for prostate cancer
  • Use of any investigational agent less than or equals to (<=)4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time
  • Major surgery <=4 weeks prior to randomization

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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