For decades, the Prostate Specific Antigen has been the most widely used test for prostate cancer screening. It also has been one of the most over-discussed and over-maligned tests of this era. Concerns about false positive results and the potential harms they cause have been the biggest concern; harms such as unnecessary prostate biopsy, biopsy complications, over diagnosis, psychological and treatment harms. These have led private and government agencies to be overly conservative and often controversial in their guidelines for PSA testing.
The latest “best new thing” is called the EpiSwitch Prostate Cancer Screening Test, or PSE which combines a regular PSA with polymerase chain reaction (PCR) evaluation with 5 DNA markers that are associated with high-risk prostate cancer. This test is non-invasive, but regrettably, it is not approved by the U.S. Food and Drug Administration AND it costs $950! Holy Cow! as Harry Caray would say about the Cubs.
Is this test that much more accurate, reliable and specific that it’s worth $950? Well, we don’t really know. There has only been one study on 109 patient blood samples. The men were age 50-69. The study compared the results of PSE testing, with all its extra bells and whistles, with regular PSA results. PSE-alone and PSA-alone results were similar for sensitivity, but PSE-alone was more specific—they found cancer at the same rate, but PSE-alone found more prostate cancers. When PSE and PSA were used jointly, cancers were found 86% of the time and 97% of them were prostate cancer.
The lack of mountains of data says PSE testing, at $950 a test, is something we better wait to have done. It’s still too iffy, and too expensive, to justify widespread use. So prostate cancer remains in that zone of confusion where everybody’s opinions differ, significant harms can come from false-positive testing, and “shared decision-making” means nobody decides about screening except the patient.
Dr.G’s Opinion: I agree the PSE test needs more study. If you’re high risk for prostate cancer, you should have a PSA, regardless of age (I had an 88 yo die with metastatic prostate cancer not detected until it was too late because he hadn’t had a PSA). The PSE has potential, but real benefit may be way off yet.
Reference: Partin M, Martin S, Newberry Z. EpiSwitch Prostate Cancer Screening Test Am Fam Phys 2025 September;112(3):325-326.?
