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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ the past 30 days

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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,588 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,522 Total Patients Enrolled

Alexander P Glaser, M.D.Principal InvestigatorNorthShore University HealthSystem

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass participants who are at least eighteen years of age?

"This clinical trial requires potential participants to be within the age range of 50-75 years old. There are 25 studies for minors and 108 for seniors outside this window."

Answered by AI

What type of person is most suitable for participation in this investigative study?

"Candidates eligible for this study must have a diagnosed enlarged prostate and be aged between 50-75 years. 70 participants are needed in total."

Answered by AI

How has adalimumab been evaluated for safety and efficacy in humans?

"Due to its Phase 2 status and preliminary evidence of safety, adalimumab has been rated a 2 on our team's scale. Unfortunately, there is still no available data supporting the efficacy of this medication."

Answered by AI

Is admissions to this research project available at the present time?

"Unfortunately, this research is not presently in need of candidates. The trial was initially posted on January 1st 2024 and the most recent update to its status came on September 25th 2023. Although there are no positions available at present, 134 other trials have open slots for applicants."

Answered by AI

What primary goals are being sought through this investigation?

"This clinical trial's primary endpoint is the evaluation of safety over a 30-day period using the Clavien-Dindo grading system. Secondary metrics include PROMIS-29 Profile v2.1, Patient Global Impression of Improvement (PGI-I) and a 3 day Voiding Diary to ascertain normal benchmarks for bladder function relative to age, gender, fluid consumption and more."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis

Lightner, Deborah J., Kevin Wymer, Joyce Sanchez, and Louis Kavoussi. 2020. “Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ju.0000000000000509.

clinicaltrials.govStudy

Effects of TNF Blockade on Human BPH/LUTS

Alexander Glaser 2024. "Effects of TNF Blockade on Human BPH/LUTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06062875.

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