Recruiting
Phase 2

Naltrexone with ADT

Sponsor:

University of Arkansas

Code:

NCT07224009

Conditions

Metastatic Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Naltrexone

Study Details

Brief 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.

Conditions

Metastatic Prostate Cancer

Study ID

NCT07224009

Start date

Aug 25, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Single-arm study of low-dose naltrexone (LDN)

Low dose Naltrexone 3 mg is taken orally once daily to be taken with food at night. Patient will be given a pill dairy to assure compliance with the medication.

Interventions

Naltrexone

Naltrexone, a structurally similar compound to the opioid antagonist naloxone, but with longer half-life and higher bioavailability, was first synthesized in the 1960s and approved by Food and Drug Administration (FDA) in 1980s for treatment of opioid addiction. Its use was later expanded for management of alcohol addiction as well. The typical dose of naltrexone used for opioid and alcohol addiction is 50-100mg \[19\].

Naltrexone at one-tenth of the original addiction treatment dose, referred to as LDN, exhibits interesting paradoxical pharmacology and enhances endogenous opioid production. It also showed exhibiting multiple other pharmacological effects ranging from inhibition of proliferation of cancer cells, modulating immune response there by slowing the progression of autoimmune diseases and exhibiting the inhibitory effect of pro-inflammatory cytokines thereby reducing the symptoms of neuropathic and non-cancer related pain.

Primary outcome measure

  • Characterize mitochondrial bioenergetics after ADT and the remediating effects of LDN [ Time Frame: 30 months ]
  • Characterize inflammation after ADT and the remediating effects of LDN [ Time Frame: 30 months ]
  • Characterize oxidative stress after ADT and the remediating effects of LDN [ Time Frame: 30 months ]
  • Assess the impact of low-dose naltrexone (LDN) on Cancer-related fatigue as measured by the FACIT-F questionnaire [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Aaron Holley

5016868274JAHolley@uams.edu

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Anuradha Kunthur, MD

501-686-8530

Principal Investigator:

Anuradha Kunthur, MD

More Information

Sponsor

University of Arkansas

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-09-08.