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The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days |
|
| Control | No Intervention | Participants receive no NSAIDs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 400 mg | Drug | 400 mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of serum PSA compared with baseline | serum prostatic specific antigen | Baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Scott Eggener, MD | Contact | 773-834-5087 | seggener@bsd.uchicago.edu | |
| Leila Yazdanbakhsh, MSCI | Contact | 7738345087 | leila.yazdanbakhsh@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Scott Eggener, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38772787 | Background | 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. | |
| 38655143 |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
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| Albany Medical College | Recruiting | Albany | New York | 12208 | United States |
|
| The Pennsylvania State University at The Milton S. Hershey Medical Center | Recruiting | Hershey | Pennsylvania | 17033 | United States |
|
| Aguiar 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. |