NCT06062875 Effects of TNF Blockade on Human BPH/LUTS
| NCT ID | NCT06062875 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Endeavor Health |
| Condition | Benign Prostatic Hyperplasia (BPH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2024-01-24 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Simon W Hayward, Ph.D.
PRINCIPAL INVESTIGATOR
Endeavor Health
Frequently Asked Questions
Who can join the NCT06062875 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 80 Years, studying Benign Prostatic Hyperplasia (BPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06062875 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06062875 currently recruiting?
Yes, NCT06062875 is actively recruiting participants. Contact the research team at MAntoniak@northshore.org for enrollment information.
Where is the NCT06062875 trial being conducted?
This trial is being conducted at Glenview, United States.
Who is sponsoring the NCT06062875 clinical trial?
NCT06062875 is sponsored by Endeavor Health. The principal investigator is Simon W Hayward, Ph.D. at Endeavor Health. The trial plans to enroll 70 participants.