Home › Enlarged Prostate (BPH) › NCT06062875
Effects of TNF Blockade on Human BPH/LUTS
RecruitingPhase 2
Who can join
Ages 45 to 80 · Men
Full eligibility criteria
Inclusion 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 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
About the study
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.
What is being tested
- Adalimumab (drug)
Sponsor: Endeavor Health · Participants: 70 · Started: Jan 24, 2024
Contact the study team
- Malgorzata Antoniak, Ph.D. · Phone: 847-503-4282
- Pooja Talaty, MS MHA CCRP · Phone: 847-503-4280
Official record on ClinicalTrials.gov — NCT06062875
Locations in the U.S.
| Illinois | NorthShore University HealthSystem, Glenview |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.