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New treatment option for Prostate Cancer
Official title Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
ClinicalTrials.gov ID: NCT05629494
What this study is testing
What is Ibuprofen 400 mg, TID?
Ibuprofen 400 mg, TID is an investigational medicine, being studied as a potential treatment for prostate cancer.
Also referred to as Motrin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prostate cancer is the most frequently diagnosed cancer in men in the Unites States. Nearly 1 million prostate biopsy procedures are performed in the United States annually and elevated prostate-specific antigen (PSA) level is the primary reason for prostate biopsy in \> 90% of cases.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- 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...
- No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Albany, New York, United States
- Hershey, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Albany, New York, United States; Hershey, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.