Investigating the effects of an anti-inflammatory drug on benign prostatic hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the efficacy of the TNF antagonist adalimumab in providing symptomatic relief and reducing prostate size in men diagnosed with benign prostatic hyperplasia (BPH). The research will assess the impact of this anti-inflammatory medication on prostate tissue and identify genetic predictors for varying responses to the treatment. Participants will be men aged 45-80 with a confirmed diagnosis of BPH, and the study will explore the potential benefits of a drug typically used for autoimmune diseases in a new patient population. The study is being conducted at NorthShore University HealthSystem with collaboration from the National Institute of Diabetes and Digestive and Kidney Diseases.

Why it matters

Who can join: the full rules

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

Where it's running

• NorthShore University HealthSystem
  Glenview, Illinois, United States Recruiting

Study contacts

• Principal investigator: Simon W Hayward, Ph.D. — Endeavor Health
• Study coordinator: Malgorzata Antoniak, Ph.D.
• Email: MAntoniak@northshore.org
• Phone: 847-503-4282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.