Bipolar Androgen Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.
• Age ≥ 18 years of age
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Histologically confirmed carcinoma of the prostate
• Progressing on continuous androgen ablative therapy (either surgical castration or LHRH agonist)
• Documented castrate level of blood testosterone (\< 50 ng/dL)
• Patients must have progressed on prior treatment with at least one Androgen Receptor Signaling Inhibitors (ARSI) and at least one chemotherapy (by prostate specific antigen \[PSA\] criteria or radiographically)
• Have biopsiable disease (a fresh biopsy is not required at baseline if adequate archival tissue is available)
• Absolute neutrophil count: ≥1,200/µL
• Platelets: ≥ 100,000/µL
• Total bilirubin: ≤ 1.2 x institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): ≤ 3 × institutional ULN
• Creatinine clearance (CrCl) \> 50 mL/min (Cockcroft-Gault equation)
• Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure