The U.S. Food and Drug Administration (FDA) has approved Cleveland Clinic’s IsoPSA, a new blood test designed to help detect high-grade (more aggressive) prostate cancer in men aged 50 and older who have elevated PSA levels.
IsoPSA is a simple blood test that helps doctors better understand why PSA levels are elevated. Unlike the standard PSA test, which measures the total amount of prostate-specific antigen in the blood, IsoPSA looks at structural changes in the PSA protein that are more closely linked to cancer. This makes the test more accurate in identifying men who may truly need a biopsy—and may help others avoid unnecessary procedures. The test has been carefully studied in large clinical trials showing that it is accurate, reliable, and useful for many men. Research also shows that IsoPSA results are not affected by common medications and can add valuable information when used along with prostate MRI.
In studies involving more than 1,700 men undergoing evaluation for prostate cancer, IsoPSA showed high accuracy in identifying aggressive, or high-grade, disease. Results from clinical trials found that the test correctly detected most high-risk cases while helping many men avoid unnecessary biopsies—reducing biopsy recommendations by more than half. Because of these strong results, IsoPSA is now included in national prostate cancer screening guidelines as an option before biopsy or for men who’ve had a previous negative biopsy but remain at higher risk.
Experts say the new test represents an important step forward in improving early detection and reducing anxiety for men facing possible prostate cancer. It gives doctors more confidence when deciding whether a biopsy is necessary, helping patients get the right care at the right time.
IsoPSA has been available since 2020 and is now covered by Medicare and many private insurance plans. The test is recognized in major clinical guidelines, including those from the National Comprehensive Cancer Network and the American Urological Association, as an option to help guide prostate cancer testing and biopsy decisions.
If you have an elevated PSA level, talk with your healthcare provider about whether IsoPSA testing may be appropriate for you. This test is intended for men age 50 and older and may help clarify your prostate cancer risk before deciding on a biopsy. Your urologist or primary care doctor can explain how IsoPSA works, where it’s available, and whether it fits into your overall care plan.
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