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New treatment option for Benign Prostatic Hyperplasia (BPH)
Official title Effects of TNF Blockade on Human BPH/LUTS
ClinicalTrials.gov ID: NCT06062875
What this study is testing
What is Adalimumab?
Adalimumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for benign prostatic hyperplasia (bph).
Also referred to as Placebo will be administered subcutaneously every 2 weeks, for a total of 6 injections..
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Specific Aim 1. To evaluate the efficacy of TNF antagonist action in BPH/LUTS Specific Aim 2.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80, men only
You may be able to join if
- Male sex
- Age 45-80 years
- Diagnosed by physician with BPH
- Prostate volume ≥ 60mL
- IPSS ≥ 8
You likely can't join if
- Female sex or intersex
- Age \ 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...
See the full eligibility 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
- Female sex or intersex
- Age \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glenview, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glenview, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.