Neoadjuvant Hormone and Radiation Therapy Followed by Radical Prostatectomy in Patients With High-Risk Prostate Cancer

Prior treatment

• Current or prior hormone therapy, radiotherapy, or chemotherapy
• Any of the following within 6 months prior to first dose of study drug: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias or New York Heart Association Class II to IV heart disease; uncomplicated deep vein thrombosis is not considered exclusionary
• History of seizure or any condition that may predispose to seizure (including, but not limited to, prior stroke, transient ischemic attack, or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)

Other illness

• Active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction
• Gastrointestinal conditions affecting absorption

Lab values

• Human immunodeficiency virus-positive subjects with 1 or more of the following:
  • Not receiving highly active antiretroviral therapy
  • Had a change in antiretroviral therapy within 6 months of the start of screening
  • Receiving antiretroviral therapy that may interfere with study drug (consult sponsor for review of medication prior to enrollment)
  • CD4 count \<350 at screening
  • AIDS-defining opportunistic infection within 6 months of start of screening

Age

• Other prior malignancy ≤5 years prior to enrollment

Other

• Pathological finding of small cell, ductal or neuroendocrine carcinoma
• Evidence of metastasis (M1) on images

• Men with age from 20 to 75 years old
• Signed an informed consent form (ICF) indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study; subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Histologically confirmed adenocarcinoma of the prostate
• High-risk locally advanced disease defined by ≥1 of the following 3 criteria:
  • T3a-3b by DRE or MRI
  • Gleason score ≥ 8 (= Grade group 4)
  • PSA ≥20 ng/ml
• Willing to undergo prostatectomy as primary treatment
• ECOG Performance status 0 or 1