Nov. 29, 2017—A study published in Prostate Cancer and Prostatic Diseases (White J, et al. Epub ahead of print Nov. 20, 2017. doi:10.1038/s41391-017-0008-7) demonstrated that physicians elected to perform fewer biopsies when Prostate Health Index (phi) testing was included in their overall, routine, clinical assessment. Phi testing is recommended for men presenting with elevated serum total prostate-specific antigen in the 4–10 ng/mL range and a nonsuspicious digital rectal exam. These men are often referred to as being in a “diagnostic gray zone,” since typically less than 35 percent of such men who are biopsied are found to be positive for prostate cancer. This potentially exposes the remaining two-thirds of such men to unnecessary complications associated with biopsies. The findings were based on a comparison of more than 500 men tested with phi to a historical control group of similar men who were seen by the same participating urologists within the previous 24 months and prior to the commercial implementation of phi testing in their practice.
The FDA-approved phi test is exclusive to Beckman Coulter and helps distinguish prostate cancer from benign conditions, using a score calculated from a combination of three blood tests. The phi score provides additional information as to what elevated PSA levels might mean and the probability of finding prostate cancer on biopsy. The phi results are intended to be used as an aid in distinguishing prostate cancer from benign prostatic conditions in men 50 years of age and older with total PSA results in the 4–10 ng/mL range and negative DRE findings. When combined with the patients’ clinical risk factors and family history, the phi score can help determine individualized patient management protocols.
“The phi test provides more information about the probability that a patient may have prostate cancer, giving both the patient and doctor additional insight to guide a decision as to whether a prostate biopsy is needed,” Michael Samoszuk, MD, chief medical officer, Beckman Coulter Diagnostics, said in a statement.