A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer

Inclusion Criteria

• •Male patients 18 years or older
• •Histologically confirmed diagnosis of adenocarcinoma of the prostate
• •Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI))
• •Testosterone levels \<50 ng/dL
• •Confirmed progressive disease defined by one or more of the following:
• •* an increase in PSA, \> 2ng/dL x 2 or more values at least 1 week apart in the setting of metastatic disease
• •* appearance of new bone lesions on bone scan
• •* progression of soft tissue lesion defined by the Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1 criteria
• •Concurrent use of an agent for testosterone suppression (e.g., Luteinizing Hormone Releasing Hormone \[LHRH\] agonist) if the patient is not surgically castrate
• •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 determined within 28 days before enrollment
• •Recovery to CTCAE grade ≤ 1 toxicity, to patient's baseline status (except alopecia), or toxicities deemed irreversible from the effects of prior cancer therapy (CTCAEs grade \> 1 that are not considered a safety risk by the investigator will be allowed)
• •Adequate bone marrow function defined as:
• •* absolute neutrophil count (ANC) \> 1500 cells/mm³ without growth factor support
• •* platelet count \> 100,000 cells/mm³ without transfusion or growth factor support
• •* hemoglobin \> 9g/dL without transfusion or growth factor support
• •Adequate liver function defined as:
• •* total bilirubin \< upper limit of normal (ULN)
• •* alanine aminotransferase (ALT) \< 1.5 x ULN
• •* aspartate aminotransferase (AST) \< 1.5 x ULN
• •Adequate renal function defined as serum creatinine level within normal limits (WNL)
• •At least a 6-month or greater life expectancy
• •Ability to understand and sign a written informed consent, which will be obtained from study participants before undergoing any study-specific procedures
• •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
• •Suitable venous access for the study-required blood sampling (i.e., including PK sampling)