RecruitingPhase 4NCT05629494

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

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

Sponsor

Albany Medical College

Enrollment

198 participants

Start Date

Sep 27, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Prostate Inflammation PSA

Summary

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a short course of ibuprofen (an anti-inflammatory drug) lowers PSA levels — the prostate-specific antigen blood test used to screen for prostate cancer. If inflammation temporarily raises PSA, treating it with ibuprofen might reduce unnecessary biopsies in men with mildly elevated PSA. **You may be eligible if...** - You are a male between 18 and 80 years old - You have an elevated PSA above 3 ng/mL and are being evaluated for possible prostate cancer (biopsy or MRI being considered) - Your digital rectal exam within the past 2 years has been normal - You have no signs of urinary tract infection **You may NOT be eligible if...** - You have an allergy or sensitivity to ibuprofen or NSAIDs - You have a history of stomach ulcers or GI bleeding - You have a bleeding disorder, severe kidney disease (eGFR below 30), or heart failure - You have known prostate cancer or had a prostate MRI or biopsy in the past year - You are taking blood thinners (other than low-dose aspirin alone) or corticosteroids - You have had urinary catheter or cystoscopy in the past 6 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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