Investigating the effects of an anti-inflammatory drug on benign prostatic hyperplasia
Effects of TNF Blockade on Human BPH/LUTS
This study is testing whether an anti-inflammatory drug can help men with benign prostatic hyperplasia feel better and reduce the size of their prostate.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | Male |
| Sponsor | Endeavor Health Academic / other |
| Drugs / interventions | adalimumab, infliximab, certolizumab, golimumab, chemotherapy, radiation |
| Locations | 1 site (Glenview, Illinois) |
| Trial ID | NCT06062875 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 45-80 who have been diagnosed with BPH and meet specific inclusion criteria.
Not a fit: Patients who are female, under 45 or over 80 years old, or have contraindications to adalimumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant symptomatic relief and improved quality of life for patients suffering from BPH.
How similar studies have performed: Previous studies have shown promising results with TNF antagonists in reducing BPH incidence in patients with autoimmune diseases, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Glenview, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.