Clinical Trials

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.
• Participants are considered eligible only if the central radiological review confirms clinical stage M0.

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.
• Prior treatment with antiandrogen.
• History of pelvic radiation for prostate cancer.
• Use of any investigational agent ≤ 4 weeks prior to randomization or any therapeutic procedure for prostate cancer at any time.
• Major surgery ≤ 4 weeks prior to randomization.