Effects of TNF Blockade on Human BPH/LUTS

• Status: Recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Male sex

• Age 45-80 years

• Diagnosed by physician with BPH

• Prostate volume ≥ 60mL

• IPSS ≥ 8

• Scheduled for BPH surgery (prostatic urethral lift, water vapor thermal therapy, transurethral resection of prostate, laser vaporization or enucleation, robotic waterjet treatment, or simple prostatectomy)

• 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

Exclusion Criteria:

• Female sex or intersex

• Age < 45 or > 80 years

• Being a prisoner or detainee

• Urinary retention with need for catheterization

• Gross hematuria

• Contraindication to treatment with adalimumab (e.g., presence of sepsis or active infection, active tuberculosis, Hepatitis B infection, invasive fungal infection, lymphoma, leukemia or other active malignancy, congestive heart failure, significant hematologic abnormality, allergy to adalimumab or its components, anti-drug antibodies, congestive heart failure)

• Diagnosis of autoimmune disease (rheumatoid arthritis, plaque psoriasis, ulcerative colitis, Crohn's disease, hidradenitis suppurativa, spondyloarthritis)

• Interstitial cystitis

• Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)

• History of lower urinary tract or pelvic malignancy including prostate cancer; history of pelvic radiation therapy

• Ongoing symptomatic urethral stricture

• Current chemotherapy or other cancer therapy

• Severe neurological or psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)

• Current moderate or severe substance use disorder