Recruiting
Phase 2

TNF Blockade

Sponsor:

Endeavor Health

Code:

NCT06062875

Conditions

Benign Prostatic Hyperplasia (BPH)

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Adalimumab

Study Details

Brief summary:

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

Benign Prostatic Hyperplasia (BPH)

Study ID

NCT06062875

Start date

Jan 24, 2024

Status verified date

Nov, 2024

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: adalimumab

adalimumab 40 mg every 2 weeks

no intervention: Placebo

placebo injection (saline) every 2 weeks.

Interventions

Adalimumab

Adalimumab will be delivered subcutaneously (under the skin) at a dose of 40mg every 2 weeks for a total of 6 doses.

Primary outcome measure

  • International Prostate Symptom Score [ Time Frame: The past 30 days ]
  • Safety as measured by Clavien-Dindo grading system [ Time Frame: Through study completion (Week 24) ]

Central Contacts and Locations

Central contacts

Malgorzata Antoniak, Ph.D.

847-503-4282MAntoniak@northshore.org

Pooja Talaty, MS MHA CCRP

847-503-4280PTalaty@northshore.org

Locations

NorthShore University HealthSystem

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Pooja Talaty, MS MHA CCRP

847-503-4280PTalaty@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Endeavor Health on 2024-11-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.