Low Dose Naltrexone to See if Fatigue Improves for Men with Prostate Cancer on Hormone Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial tests whether a 3 mg daily dose of low-dose naltrexone can safely improve energy levels in men receiving androgen deprivation therapy, with or without newer hormonal medicines. The study will examine mitochondrial function, inflammation, and oxidative stress, along with cancer-related fatigue measured by the FACIT-F questionnaire. Secondary goals include quality of life (FACT-P) and overall safety and tolerability of LDN. Eligible participants have metastatic prostate cancer, are on ADT for at least 3 months, and meet standard health criteria; those recently treated with chemotherapy or on certain PARP inhibitors are excluded. The investigation is led by the University of Arkansas at Medical Sciences, with participation centered at that site.

Why it matters

Who can join: the full rules

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, 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.

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting

Study contacts

• Study coordinator: Aaron Holley
• Email: JAHolley@uams.edu
• Phone: 5016868274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.