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Monoclonal Antibodies

Adalimumab for Enlarged Prostate

Phase 2
Recruiting
Led By Simon W Hayward, Ph.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)
Must not have
Gross hematuria
Interstitial cystitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (week 24)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have visible blood in my urine.
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I have been diagnosed with interstitial cystitis.
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I am currently undergoing chemotherapy or other cancer treatments.
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I have been diagnosed with an autoimmune disease.
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I do not have severe mental health issues like bipolar disorder or Alzheimer's.
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I identify as female or intersex.
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I am currently experiencing symptoms from a narrowed urethra.
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I have not had pelvic or specific urinary surgery in the last 6 months.
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I have had cancer in my lower urinary tract, pelvis, or prostate, or I've received radiation therapy in the pelvic area.
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I need a catheter to help me urinate.
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I am younger than 50 or older than 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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
737,572 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,448 Previous Clinical Trials
4,332,349 Total Patients Enrolled
Simon W Hayward, Ph.D.Principal InvestigatorNorthShore University HealthSystem
~47 spots leftby Apr 2028
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