Effects of TNF Blockade on Human BPH/LUTS
ConditionBenign Prostatic Hyperplasia (BPH)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age45-80
SponsorEndeavor Health
About this trial
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
Qualifiers
Male sex
Age 45-80 years
Diagnosed by physician with BPH
Prostate volume ≥ 60mL
Disqualifiers
Female sex or intersex
Age < 45 or > 80 years
Being a prisoner or detainee
Urinary retention with need for catheterization
Trial design
Treatments tested in this trial
- Adalimumab
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Endeavor Health
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov