Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT05629494
Eligibility Criteria:
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 within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.
* No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
Exclusion Criteria:
* History of hypersensitivity or allergy to ibuprofen or NSAIDs.
* History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events
* Known bleeding disorders
* Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
* Heart failure, significant heart disease
* Poorly controlled hypertension
* Active urinary tract infections or bacteriuria
* Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months
* Known prostate cancer or underwent prostate MRI or biopsy in the last year
* Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)
* Concomitant anti-inflammatory or steroidal drugs
* Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone
* Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT \> 3X ULN based on exiting history or labs)
* Any other medical contraindication to NSAIDs
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05629494
Study Brief:
Protocol Section:
NCT05629494