Effects of TNF Blockade on Human BPH/LUTS

Description

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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Overview

Study Details

Study overview

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.

Effects of TNF Blockade on Human BPH/LUTS

Effects of TNF Blockade on Human BPH/LUTS

Condition
Benign Prostatic Hyperplasia (BPH)
Intervention / Treatment

-

Contacts and Locations

Glenview

NorthShore University HealthSystem, Glenview, Illinois, United States, 60026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NorthShore University HealthSystem,

Simon W Hayward, Ph.D., PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Alexander P Glaser, M.D., PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

2028-06-01