Elevated Serum PSA
Conditions
Keywords
PSA
Brief summary
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.
Interventions
DRUGIbuprofen 400 mg
400 mg tablet
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum PSA compared with baseline | Baseline, 6 weeks | serum prostatic specific antigen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of International Prostate Symptom Score (IPSS) compared with baseline | Baseline, 6 weeks | Self-reported questionnaires measured lower urinary tract symptoms ranging from 0 to 35. Higher score mean worse outcomes. |
Countries
United States
Contacts
Primary ContactScott Eggener, MD
Backup ContactLeila Yazdanbakhsh, MSCI
Outcome results
None listed