About this trial
The study is being done to see if a small daily dose of naltrexone (LDN, 3 mg pill) can help reduce tiredness (fatigue) in men with prostate cancer. All men in this study are being treated with hormone therapy (also called androgen deprivation therapy, or ADT). Some may also be taking newer hormone medicines such as apalutamide, daralutamide, enzalutamide, or abiraterone.
Eligibility criteria
Qualifiers
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.
leukocytes >3,000/μL
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Naltrexone