Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Depri… (NCT07224009) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
60 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterize mitochondrial bioenergetics after ADT and the remediating effects of LDN
Timeframe: 30 months
2
Characterize inflammation after ADT and the remediating effects of LDN
Timeframe: 30 months
3
Characterize oxidative stress after ADT and the remediating effects of LDN
Timeframe: 30 months
4
Assess the impact of low-dose naltrexone (LDN) on Cancer-related fatigue as measured by the FACIT-F questionnaire