Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

Inclusion Criteria:

* Histologic confirmed prostatic adenocarcinoma
* Non-castrate levels of testosterone (\> 150 ng/dL)
* High-risk localized prostate cancer, defined by either:

  * Tumor stage T3 by digital rectal examination, or
  * Primary tumor Gleason score ≥ 8, or
  * PSA ≥ 20 ng/mL
* Willing to undergo prostatectomy as primary treatment for localized prostate cancer
* Adequate hematologic, renal and hepatic function:

  * WBC \> 3000/uL
  * Platelets \> 150,000/uL
  * Creatinine \< 2 mg/dL
  * Bilirubin \< 1.5 x upper limit of normal (ULN)
  * AST/ALT \< 2 x ULN
* Karnofsky Performance Status (KPS) ≥ 80%
* Able to swallow the study drugs whole as tablets

Exclusion Criteria:

* Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
* Current or prior hormonal therapy, radiation therapy or chemotherapy for prostate cancer
* Evidence of metastatic disease (M1) on imaging studies
* Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma
* Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure
* History of prior cardiac arrhythmia.
* Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.