Effects of TNF Blockade on Human BPH/LUTS

Launched by ENDEAVOR HEALTH · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication that blocks a specific protein (TNF) on men with benign prostatic hyperplasia (BPH), which is a condition where the prostate gland becomes enlarged and causes urinary problems. The trial aims to see if this treatment can improve symptoms related to BPH, examine how it affects prostate tissue, and identify any genetic factors that might predict how well different patients will respond to the treatment.

To participate in this trial, men aged 45 to 80 who have been diagnosed with BPH and are scheduled for certain types of prostate surgery may be eligible. Participants will need to complete questionnaires and provide consent, and they should be able to read and speak English. Importantly, those who have previously received certain TNF inhibitors or have specific medical conditions may not qualify. If you join the study, you can expect to receive care and monitoring related to your BPH while contributing to important research that could help others in the future.

Gender

MALE

Eligibility 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