Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)

Prior treatment

• Prior chemotherapy received in the last three months.
• Patients currently on PARP inhibitors.
• Currently taking or have taken within 10 days of enrollment.
• Patients may not be receiving any other investigational agents.

Other illness

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Naltrexone or other agents used in the study.
• History of other malignancies other than nonmelanoma skin cancer, unless in complete remission and off therapy for that disease for at least 5 years.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, history of congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Any Patient with acute hepatitis and liver failure are excluded.

• Histologically or cytologically confirmed biochemical recurrence and on ADT for at least 3 months. Metastatic castrate-sensitive and castrate-resistant prostate cancer on ADT with or without novel hormonal therapy like apalutamide, darolutamide, enzalutamide and abiraterone.
• Initiation of hormonal ablative therapy within 3 months of registration.
• ECOG performance status \<3.
• Patients must have normal organ and marrow function as defined below:
  • leukocytes \>3,000/μL
  • absolute neutrophil count \>1,500/μL
  • platelets \>100,000/μL
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
  • creatinine ≤2.5.0
  • left ventricular ejection fraction \>45%
  • FACIT-F score \< 43 on screening
• Ability to understand and the willingness to sign a written informed consent document.