Albany Medical College
Badar M. Mian
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.
Prostate Cancer
Prostate Inflammation
PSA
Ibuprofen 400 mg, TID
PSA test
PHASE4
It's known that PSA level can be elevated due to reasons other than prostate cancer including benign prostatic hypertrophy, prostatitis or other urinary tract infections, non-infectious inflammation, and physiologic variation over time. Consequently, nearly 50% of prostate biopsy procedures performed due to elevated PSA level do not yield any cancer , but still expose the patients to the risks of the procedure related complications (discomfort/pain, anxiety, bleeding, infection, and cost). Thus, measures to improve the reliability of PSA test, and potentially avoiding unnecessary procedures, are of significant importance to the patient and healthcare system. It is common practice to check PSA level annually. PSA test results can vary over time, either due to the imprecision in the analysis and/or due to the biologic variability. This can result in an apparent rise in PSA level when no clinically meaningful rise had occurred. Its estimated that the average lab variation in PSA was approximately 6% and the average biologic variation about 14%. This, it is recommended that isolated elevation in PSA level should be confirmed after several weeks, and before proceeding with further interventions, including prostate biopsy. Sub-clinical, histologic Inflammation (presence of inflammatory cells) within the prostate tissue and its effect on PSA level has been reported in various settings. In two population-based studies, men who were regularly using over the counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs, e.g ibuprofen, naproxen) had lower PSA levels compared to non-users. Currently, two strategies are utilized in clinical practice to ensure that the PSA level is truly elevated: 1. Repeat PSA test after several weeks or 2. A short course of OTC NSAIDs, and then repeat PSA test Investigators propose to conduct a randomized study to determine the effect of NSAIDs on PSA level compared to the biologic variations in PSA level noted upon repeat testing.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 198 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level |
| Actual Study Start Date : | 2022-09-27 |
| Estimated Primary Completion Date : | 2026-03-01 |
| Estimated Study Completion Date : | 2026-12-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 80 Years |
| Sexes Eligible for Study: | MALE |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
RECRUITING
Albany Medical Center
Albany, New York, United States, 12208
RECRUITING
Penn State-Hershey Medical Center
Hershey, Pennsylvania, United States, 17033