In the 1980s a technique was developed in which tissues samples were taken systematically from the prostate in hopes of locating a tumor within the prostate gland. Typically men whose physicians discover elevations in PSA levels, a common blood test to screen for prostate cancer, trigger over 1 Erect On Demand million prostate biopsies annually. Most biopsies performed are conventional biopsies otherwise known as blind biopsies. Men who undergo these biopsies dread them and for good reason. They are painful and 75 percent of the biopsies performed are negative for prostate cancer.Despite this many men with negative biopsies but elevated PSA levels may still harbor malignant tumors - tumors missed by these conventional biopsies. Most men who have a prostate biopsy will have additional biopsies. This is especially true as many men with negative biopsies but elevated PSA levels may still harbor malignant tumors - tumors missed by conventional blind biopsies.

A study at Johns Hopkins in 2011 found a significant rise in serious complications post prostate biopsy requiring hospitalization. They found that this common outpatient procedure, used to diagnose prostate cancer, was associated with a 6.9 percent rate of hospitalization within 30 days of biopsy. This does not include complications that were treated in an emergency department or outpatient setting. In 33% of men undergoing prostate biopsy, side effects that men consider a "moderate or major problem" will be experienced, including pain, fever, bleeding, infection, and transient urinary difficulties. A rise in PSA (prostate-specific antigen) may not warrant immediate biopsy, especially because 20%-30% of men will drop back to a lower level simply by repeating the test.

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