Effects of TNF Blockade on Human BPH/LUTS
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Benign Prostatic Hyperplasia (BPH)
In brief
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.
Key facts
- Study ID
- NCT06062875
- Run by
- Endeavor Health
- People needed
- 70
- Starts
- 2024-01-24
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2024-11-21
Who can join
Age: 45 and older, up to 80. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- NorthShore University HealthSystem — Glenview, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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