Prevent Unneeded Biopsies with IsoPSA


CLEVELAND, Ohio (Ivanhoe Newswire)— Every year, 1.3 million men in the United States undergo biopsies to determine if they have prostate cancer. Doctors usually recommend a biopsy if a man’s PSA level is four or higher. But the PSA screening test alone can’t determine if a man has cancer or something else. More on a new lab test that could eliminate unneeded biopsies, IsoPSA

For men age 50 and over, the PSA or prostate-specific antigen blood test, has been the recommended screening test for prostate cancer for years. It’s also a test that some experts have criticized because of the chance for false positive results. Now, scientists are studying a new lab test that is proving to be more accurate.

“It’s a new way of measuring all the different abnormal proteins that result when cancer occurs as opposed to the normal proteins when PSA goes up because of non-cancerous prostate enlargement,” explained Eric Klein, MD, chair of Glickman Urological & Kidney Institute at Cleveland Clinic.

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Cleveland Clinic researchers studied the IsoPSA test in two separate studies and found more than forty percent of biopsies could have been avoided. Down the road, it could change clinical practice.

“So IsoPSA adds to the toolbox because it will allow us to more accurately identify men at highest risk for high-grade cancers and only do biopsies in those patients and avoid biopsies in patients who don’t really need a biopsy,” elaborated Dr. Klein.

For men, that eliminates unnecessary procedures and adds to their peace of mind.

IsoPSA is now commercially available in select areas across the U.S. The company that developed the test, Cleveland Diagnostics, is preparing an application for FDA approval that should be considered by the agency in the first quarter of this year (2021). If the FDA approves the test, it’s likely it will gain coverage by insurance companies. Right now, the IsoPSA is available at certain U.S. hospitals and clinics with a 450-dollar out-of-pocket cost for the patient.

Contributors to this news report include: Cyndy McGrath, Executive & Field Producer; Roque Correa, Editor.

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REPORT:     MB #4843

PROSTATE CANCER: Prostate cancer begins when cells in the prostate gland start to grow out of control. The prostate is found only in males and makes some of the fluid that is part of semen. The prostate is below the bladder and in front of the rectum. Just behind the prostate are glands called seminal vesicles that make most of the fluid for semen. The urethra, which is the tube that carries urine and semen out of the body through the penis, goes through the center of the prostate. Almost all prostate cancers are adenocarcinomas which are cancers that develop from the gland cells. Other types of cancers that can start in the prostate but are rare include small cell carcinomas, neuroendocrine tumors, transitional cell carcinomas, and sarcomas. Prostate cancer is found when a man has a prostate biopsy. When looking at the biopsy a doctor will look at the pattern of the cells which will tell them whether it is a low-grade prostatic intraepithelial neoplasia (PIN) where the cells appear normal or a high-grade PIN where cell patterns look abnormal.


CONVENTIONAL PROSTATE CANCER SCREENING TESTS: Prostate screening tests might include a digital rectal exam (DRE). During a DRE, your doctor inserts a gloved, lubricated finger into your rectum to examine your prostate, which is adjacent to the rectum. If your doctor finds any abnormalities in the texture, shape, or size of the gland, you may need further tests. Your doctor may also do a prostate-specific antigen (PSA) test where a blood sample is drawn from a vein in your arm and analyzed for PSA, a substance that is naturally produced by your prostate gland. It is normal for a small amount of PSA to be in your bloodstream. However, if a higher than usual level is found, it may indicate prostate infection, inflammation, enlargement, or cancer.


ISOPSA TEST: It is a blood-based diagnostic test that has superiority over conventional tests in predicting the presence of high-grade prostate cancer, potentially resulting in a significant decrease in unnecessary prostate biopsies by differentiating between the risks of high-grade and low-grade cancer or benign biopsies. The conventional PSA Test has limitations, most notably its imprecision when detecting the aggressiveness of a malignancy. The IsoPSA is a reflex test that takes a different biological approach. It examines structural changes in a patient’s PSA levels because of disease pathogenesis, rather than assessing the concentration of the protein. The IsoPSA test will offer new clinical data points to guide the physician-patient conversation about the prostate cancer biopsy.





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Doctor Q and A

Read the entire Doctor Q&A for Eric Klein, MD, Chairman of the Glickman Urological and Kidney Institute

Read the entire Q&A