RECRUITING

Effects of TNF Blockade on Human BPH/LUTS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of TNF Blockade on Human BPH/LUTS

Quick Facts

Study Start:2024-01-24

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06062875

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 80 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * Microscopic hematuria without appropriate workup per AUA/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) Guidelines * Positive urine culture	* 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

Inclusion Criteria

Exclusion 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
* Microscopic hematuria without appropriate workup per AUA/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) Guidelines
* Positive urine culture

* 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

Contacts and Locations

Study Contact

Malgorzata Antoniak, Ph.D.

CONTACT

847-503-4282

MAntoniak@northshore.org

Pooja Talaty, MS MHA CCRP

CONTACT

847-503-4280

PTalaty@northshore.org

Principal Investigator

Simon W Hayward, Ph.D.

PRINCIPAL_INVESTIGATOR

NorthShore University HealthSystem

Alexander P Glaser, M.D.

PRINCIPAL_INVESTIGATOR

NorthShore University HealthSystem

Study Locations (Sites)

NorthShore University HealthSystem

Glenview, Illinois, 60026

United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

Simon W Hayward, Ph.D., PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem
Alexander P Glaser, M.D., PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-24

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2024-01-24

Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

Benign Prostatic Hyperplasia (BPH)