Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen

The University of Chicago

Status and phase

Enrolling

Phase 4

Conditions

Elevated Serum PSA

Treatments

Drug: Ibuprofen 400 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05512754

IRB21-1952

Details and patient eligibility

About

The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

Full 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.

Enrollment

200 estimated patients

Sex

Male

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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