Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer

Inclusion Criteria

• •1. Histologically or cytologically confirmed prostate cancer with documented metastatic disease
• •2. Evidence of castrate testosterone level \<50ng/dl (or surgical castration)
• •3. Evidence of disease progression:
• •* 2 or more new lesions on bone scan or
• •* Progressive disease on CT/MRI according to Response Evaluation Criteria in Solid Tumors 1.1 criteria or
• •* Rising Prostate Specific Antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart.
• •4. Prior treatment with at least one line of potent androgen receptor signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide) in either castration-sensitive or castration-resistant setting.
• •5. Any prior therapy for castrate disease is acceptable except prior GR antagonist treatment (e.g. mifepristone or relacorilant).
• •6. Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug.
• •7. Denosumab or zoledronic acid are allowed.
• •8. ECOG performance status ≤ 2.
• •9. Patients must have normal hepatic function as defined below:
• •* Total bilirubin \</=1.5 x the upper limit of normal
• •* AST(SGOT)/ALT(SGPT) \</=2.5 X institutional upper limit of normal
• •* Albumin \>/=3.0 g/dL
• •10. Patients must have normal bone marrow function as defined below:
• •* Platelet count (plt) \>/= 80,000 /microliter
• •* Hemoglobin (Hgb) \>/= 9 g/dL
• •* Absolute neutrophil count (ANC) \>/= 1500
• •11. Patients must have normal renal function as defined below:
• •* GFR \>/= 30 mL/min
• •12. Ability to understand and the willingness to sign a written informed consent document.
• •13. Patients with active Diabetes Mellitus on glucose lowering medications are eligible provided they agree to and are able to self-monitor daily blood glucose levels due to potential risk of lowering glucose levels on relacorilant.
• •14. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one 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); AND
• •* One of the following is required:
• •1. Established use of oral, or injected or implanted hormonal method of contraception by the female partner;
• •2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner;
• •3. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner;
• •4. Tubal ligation in the female partner;
• •5. Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months.