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Nonsteroidal Anti-inflammatory Drug

Ibuprofen for Elevated PSA Levels

Phase 4
Recruiting
Led By Scott Eggener, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test whether ibuprofen can lower PSA levels in men with slightly elevated levels, which may help prevent prostate cancer.

Who is the study for?
This trial is for men aged 18-80 with a PSA level over 3 ng/ml who are being considered for further prostate tests but have no symptoms of urinary infection or known prostate cancer. They must not be on blood thinners, anti-inflammatory drugs, have severe liver/kidney disease, history of GI bleeding, urethral catheter use recently, or NSAID allergies.
What is being tested?
The study is testing the effects of taking ibuprofen (400 mg) on men with elevated PSA levels to see if it impacts their need for additional diagnostic procedures like MRI or biopsy.
What are the potential side effects?
Possible side effects include digestive issues such as stomach pain and heartburn, increased risk of gastrointestinal bleeding especially in those with a history of ulcers or bleeds, and potential kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change of serum PSA compared with baseline
Secondary study objectives
Change of International Prostate Symptom Score (IPSS) compared with baseline

Side effects data

From 2023 Phase 4 trial • 198 Patients • NCT04611529
2%
Headache
2%
Chills
2%
Diarrhea
2%
Dizziness
2%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Ibuprofen + Topical Diclofenac
Oral Ibuprofen + Topical Placebo
Oral Placebo + Topical Diclofenac

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IbuprofenExperimental Treatment1 Intervention
Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days
Group II: ControlActive Control1 Intervention
Participants receive no NSAIDs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen 400 mg
2021
Completed Phase 4
~2000

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,055 Previous Clinical Trials
760,509 Total Patients Enrolled
Scott Eggener, MDPrincipal InvestigatorUniversity of Chicago
5 Previous Clinical Trials
710 Total Patients Enrolled

Media Library

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05512754 — Phase 4
Prostate Specific Antigen Test Research Study Groups: Ibuprofen, Control
Prostate Specific Antigen Test Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT05512754 — Phase 4
Ibuprofen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05512754 — Phase 4
~44 spots leftby Aug 2025
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