🏛️ Verified NIH Record • Updated 2024-10-17

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test (NCT05629494)

Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Albany Medical College

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (15 items).

Location: University of Chicago Medical Center — Chicago, Illinois

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

  • University of Chicago Medical Center — Chicago, Illinois
  • Albany Medical Center — Albany, New York
  • Penn State-Hershey Medical Center — Hershey, Pennsylvania

📞 Contact the Study Coordinator

Phone: (518) 262-8579

Email: amcurologyresearch@amc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗