NCT05629494RecruitingPhase 4
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level
Source: ClinicalTrials.gov · Last updated 18 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. However, at the PSA levels which trigger prostate biopsy, often no cancer is found in prostate biopsy specimens. PSA test can be elevated due to reasons other than cancer such as inflammation or natural variation in the level. Investigators plan to treat men with elevated PSA level with over the counter anti-inflammatory medications (ibuprofen, naproxen) to see if the PSA level will decrease to an acceptable level.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 3 Sept 2022
- Start date
- 27 Sept 2022
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Albany Medical College
- Diseases
- Prostate cancer
- NCT number
- NCT05629494
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 198
- From 27 Sept 2022 to the primary completion date, 1 Mar 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months
- Concomitant anti-inflammatory or steroidal drugs
- Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone
Other illness
- 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
- Heart failure, significant heart disease
- Poorly controlled hypertension
- Active urinary tract infections or bacteriuria
- Known prostate cancer or underwent prostate MRI or biopsy in the last year
Lab values
- Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
- Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT \> 3X ULN based on exiting history or labs)
Other
- Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)
- Any other medical contraindication to NSAIDs
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Penn State Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.