Status:
RECRUITING
Effects of TNF Blockade on Human BPH/LUTS
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
45-80 years
Phase:
PHASE2
Brief 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 pred...
Detailed Description
The purpose of this study is to investigate whether an anti-inflammatory drug commonly used for a range of autoimmune diseases may be useful to provide symptomatic relief, prostate shrinkage, and/or d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06062875
Start Date
January 24 2024
End Date
June 1 2028
Last Update
November 21 2024
Active Locations (1)
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1
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026