RecruitingPhase 2NCT06062875

Effects of TNF Blockade on Human BPH/LUTS

Sponsor

Endeavor Health

Enrollment

70 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia (BPH)

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.

Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 80 Years

Inclusion Criteria13

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 Criteria14

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