Actively Recruiting

Phase 2
Age: 45Years - 80Years
MALE
NCT06062875

Effects of TNF Blockade on Human BPH/LUTS

Led by Endeavor Health · Updated on 2024-11-21

70

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

Sponsors

E

Endeavor Health

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Effects of TNF Blockade on Human BPH/LUTS

Who Can Participate

Age: 45Years - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NorthShore University HealthSystem

Glenview, Illinois, United States, 60026

Actively Recruiting

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Research Team

M

Malgorzata Antoniak, Ph.D.

CONTACT

P

Pooja Talaty, MS MHA CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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