Effects of TNF Blockade on Human BPH/LUTS

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Specific Aim 1. To evaluate the efficacy of TNF antagonist action in BPH/LUTS Specific Aim 2. Define the consequences of TNF antagonist therapy on prostate tissue Specific Aim 3. Identify genetic predictors to stratify patients with differential response to TNF-antagonist therapy.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• Male sex

• Age 45-80 years

• Diagnosed by physician with BPH

• Prostate volume ≥ 60mL

• IPSS ≥ 8

• Able and willing to complete questionnaires

• Able and willing to provide informed consent

• Able to read, write, and speak in English

• No prior treatment with TNF inhibitor (adalimumab, etanercept, infliximab, certolizumab, golimumab)

• No plans to move from study area in the next 6 months

⁃ Deferral Criteria:

• Microscopic hematuria without appropriate workup per AUA/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) Guidelines

• Positive urine culture

Locations
United States
Illinois
NorthShore University HealthSystem
RECRUITING
Glenview
Contact Information
Primary
Malgorzata Antoniak, Ph.D.
MAntoniak@northshore.org
847-503-4282
Backup
Pooja Talaty, MS MHA CCRP
PTalaty@northshore.org
847-503-4280
Time Frame
Start Date: 2024-01-24
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 70
Treatments
Active_comparator: adalimumab
adalimumab 40 mg every 2 weeks
No_intervention: Placebo
placebo injection (saline) every 2 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Endeavor Health

This content was sourced from clinicaltrials.gov