Elevated Serum PSAPhase 4NCT05512754
Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
A Phase 4 study testing Ibuprofen 400 mg in people with Elevated Serum PSA, run by University of Chicago at 3 sites in United States.
Trial summary
The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Elevated Serum PSA
- What is being tested?
- Ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2022to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients age between 18-80 years old with a screening PSA > 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
- Normal digital rectal examination.
- No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
Who cannot join
- Active urinary tract infections or bacteriuria
- Known prostate cancer
- Urethral catheter within the last 6 weeks
- History of hypersensitivity or allergy to ibuprofen or NSAIDs.
- Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
- Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
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- History of gastrointestinal bleeding or NSAIDs induced GI adverse events
- Concomitant dual-antiplatelet use or anticoagulants
- Concomitant anti-inflammatory or steroidal drugs
- Known bleeding disorder(s)
- Patients with a solitary kidney or history of a kidney transplant
- Any other medical contraindication to NSAIDs
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12208
Badar Mian, MD, 518-262-8579, amcurologyresearch@amc.edu
Brenda Romeo, romeob@amc.edu
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Scott Eggener, MD, 773-834-5087, seggener@bsd.uchicago.edu
Leila Yazdanbakhsh, MSCI, 7738345087, leila.yazdanbakhsh@bsd.uchicago.edu
- Recruiting
The Pennsylvania State University at The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Jay Raman, MD, 717-531-8848, jraman@pennstatehealth.psu.edu
Dennis Head, dhead@pennstatehealth.psu.edu
About this study
Official title: Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.
Read the detailed description
Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.
- Conditions
- Elevated Serum PSA
- Being tested
- Ibuprofen 400 mg
- Keywords
- PSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mgDrug
Also called Advil
400 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days Receives: Drug: Ibuprofen 400 mg |
| Control | No intervention | Participants receive no NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum PSA compared with baseline
serum prostatic specific antigen
Measured: Baseline, 6 weeks
Secondary outcomes (1)
Change of International Prostate Symptom Score (IPSS) compared with baseline
Self-reported questionnaires measured lower urinary tract symptoms ranging from 0 to 35.
Higher score mean worse outcomes.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elevated Serum PSAStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Eggener, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512754
- Sponsor's protocol ID
- IRB21-1952
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Josefsson A, Mansson M, Kohestani K, Spyratou V, Wallstrom J, Hellstrom M, Lilja H, Vickers A, Carlsson SV, Godtman R, Hugosson J. Performance of 4Kscore as a Reflex Test to Prostate-specific Antigen in the GOTEBORG-2 Prostate Cancer Screening Trial. Eur Urol. 2024 Sep;86(3):223-229. doi: 10.1016/j.eururo.2024.04.037. Epub 2024 May 20.
PubMed 38772787Aguiar JA, Li EV, Ho A, Bennett R 4th, Li Y, Neill C, Schaeffer EM, Patel HD, Ross AE. Ultrasensitive PSA: rethinking post-surgical management for node positive prostate cancer. Front Oncol. 2024 Apr 9;14:1363009. doi: 10.3389/fonc.2024.1363009. eCollection 2024.
PubMed 38655143
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
- ClinicalTrials.gov ID
- NCT05512754
- Acronym / sponsor ID
- IRB21-1952
- Conditions
- Elevated Serum PSA
- Keywords
- PSA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.
Detailed description
Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen 400 mgParticipants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days |
| Control | No intervention | –Participants receive no NSAIDs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients age between 18-80 years old with a screening PSA > 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
- Normal digital rectal examination.
- No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
Key exclusion criteria (12 listed)
- Active urinary tract infections or bacteriuria
- Known prostate cancer
- Urethral catheter within the last 6 weeks
- History of hypersensitivity or allergy to ibuprofen or NSAIDs.
- Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 400 mgAlso: Advil400 mg tablet | Drug | Ibuprofen |
Primary outcome
Change of serum PSA compared with baseline
Time frame: Baseline, 6 weeks
serum prostatic specific antigen
1 secondary outcome
Change of International Prostate Symptom Score (IPSS) compared with baseline
Time frame: Baseline, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Background: PubMed 38772787Josefsson A, Mansson M, Kohestani K, Spyratou V, Wallstrom J, Hellstrom M, Lilja H, Vickers A, Carlsson SV, Godtman R, Hugosson J. Performance of 4Kscore as a Reflex Test to Prostate-specific Antigen in the GOTEBORG-2 Prostate Cancer Screening Trial. Eur Urol. 2024 Sep;86(3):223-229. doi: 10.1016/j.eururo.2024.04.037. Epub 2024 May 20.
- Background: PubMed 38655143Aguiar JA, Li EV, Ho A, Bennett R 4th, Li Y, Neill C, Schaeffer EM, Patel HD, Ross AE. Ultrasensitive PSA: rethinking post-surgical management for node positive prostate cancer. Front Oncol. 2024 Apr 9;14:1363009. doi: 10.3389/fonc.2024.1363009. eCollection 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott Eggener, MD principal investigator
University of Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 400 mg in people with Elevated Serum PSA, run by University of Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Eggener, MD (773-834-5087, seggener@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum PSA compared with baseline (time frame: Baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.