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Monoclonal Antibodies

Adalimumab for Enlarged Prostate

Phase 2
Recruiting
Led By Alexander P Glaser, M.D.
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed by physician with BPH
No prior treatment with TNF inhibitor (adalimumab, etanercept, infliximab, certolizumab, golimumab)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (week 24)
Awards & highlights

Study Summary

This trial studies the effects of a drug to treat BPH/LUTS, and how it affects prostate tissue & identifies genes to predict who will respond to the drug.

Who is the study for?
Men aged 50-75 with a prostate volume ≥ 80mL and moderate to severe urinary symptoms (IPSS ≥ 8), diagnosed with BPH, scheduled for surgery, who haven't used TNF inhibitors like adalimumab before. Excludes those with catheter-dependent urinary retention, active infections or cancer, recent pelvic surgeries, autoimmune diseases, certain neurological/psychiatric disorders or substance abuse.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Adalimumab, a TNF blocker medication on men with enlarged prostates causing urinary issues. It aims to assess symptom relief post-treatment and identify genetic markers predicting patient response.See study design
What are the potential side effects?
Adalimumab may cause injection site reactions, increased risk of infection including tuberculosis and fungal infections; possible allergic reactions; heart failure; blood disorders; liver problems such as Hepatitis B reactivation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with an enlarged prostate.
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I have never been treated with TNF inhibitors.
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I am scheduled for surgery to treat an enlarged prostate.
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I am male.
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My prostate is larger than 80mL.
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I am between 50 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the past 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and the past 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International Prostate Symptom Score
Safety as measured by Clavien-Dindo grading system
Secondary outcome measures
3-Day Voiding Diary
Change in PVR (post-void residual)
Change in maximum flow rate (uroflowmetry)
+5 more
Other outcome measures
Cellular consequences of adalimumab therapy on prostate tissue
Genetic predictors to stratify patients with differential response to adalimumab

Trial Design

2Treatment groups
Active Control
Group I: PlaceboActive Control1 Intervention
placebo injection (saline) every 2 weeks.
Group II: adalimumabActive Control1 Intervention
adalimumab 40 mg every 2 weeks

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,548 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,378 Previous Clinical Trials
4,315,401 Total Patients Enrolled
Alexander P Glaser, M.D.Principal InvestigatorNorthShore University HealthSystem
~47 spots leftby Apr 2028
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