Patients with non-suspicious digital rectal exam findings and total PSA in the 4.0- to 10.0-ng/mL range are far less likely to be biopsied if they’ve had Prostate Health Index (phi) testing than if they don’t, according to a new study.
“Inclusion of the phi test provides more information about the probability that a patient may have prostate cancer, further informing the decision on whether a prostate biopsy is needed,” said lead study author Jay White, PhD, MPH, of Carolina Urology Partners, Huntersville, NC. “In recent years, there has been an indictment of PSA screening, most notably from the U.S. Preventive Services Task Force. With this study of the clinical utility of phi, which includes PSA as well as free PSA and [–2] proPSA, we can clearly see an improvement in clinical decision-making and patient management with respect to screening for prostate cancer.”
This is the first multicenter study, reflecting results from four large urology practices around the U.S., to analyze phi testing’s impact in real-world practice. The findings were published online in Prostate Cancer and Prostatic Diseases (Nov. 20, 2017).
The authors used a test shown to improve diagnostic accuracy, the FDA-approved phi, which combines three immunoassays—total PSA, free PSA, and [–2] proPSA—into a single numerical phi score.
Researchers conducting the pivotal trial for FDA approval found the phi test resulted in nearly a threefold prostate cancer detection improvement, compared to total PSA alone. A later meta-analysis of nearly 3,000 patients suggested a pooled clinical specificity of 31.6% at the 90% sensitivity threshold, according to the study.
For the current study, the authors compared urologists’ management of a prospective group of 506 men, ages 50 years and older, with total serum PSA between 4.0 ng/mL and 10.0 ng/mL and nonsuspicious digital rectal exam findings who had phi testing, to a like cohort of 683 men who didn’t receive phi testing.