Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer

Inclusion Criteria

• •Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
• •NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
• •Males 18 years of age and above
• •Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
• •Having documented disease progression on enzalutamide defined by 1 or more of the following criteria:
• •PSA progression according to PCWG2 criteria with 3 consecutive rising PSA measurements, all collected at least 1 week apart
• •Radiographic progression in soft tissue or bone by modified RECIST 1.1 for subjects with measurable disease; or
• •Bone disease progression defined by 2 or more new lesions on 2 consecutive bone scans in the absence of falling PSA
• •Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRG-analogue therapy for the duration of the trial
• •Serum testosterone level \< 50 ng/dL at Screening visit
• •ECOG PS: 0-1
• •Throughout the study, male patients and their female partners of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
• •Condom (barrier method of contraception even if having sex with a pregnant woman)
• •One of the following is required:
• •* Established use of oral, injected, or implanted hormonal method of contraception by the female partner
• •* Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner
• •* Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
• •* Tubal litigation in the female partner
• •* Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy) for \>6 months
• •Patients must have adequate organ and marrow function as defined below
• •Leukocytes \>3,000/mm3
• •absolute neutrophil count \>1,500/mm3
• •platelets \>100,000/mm3
• •total bilirubin within normal institutional limits (or \<2X the upper limit of normal in those with Gilbert's disease)
• •AST(SGOT)/ALT(SGPT) \<1.5 X institutional upper limit of normal
• •creatinine within normal institutional limits OR
• •creatinine clearance\* \>45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• •Estimated life expectancy of \> 6 months
• •Able to swallow the study drug as prescribed and comply with study requirements