Performance of the Prostate Health Index Test in Men With Prostate Specific Antigen Levels Between 10 and 20 ng/mL.

OBJECTIVE

To examine the role of Prostate Health Index (PHI) in detecting clinically significant cancer among biopsy-naïve men with a prostate specific antigen (PSA) between 10-20 ng/mL.

METHODS

We studied biopsy-naïve men who underwent PHI testing followed by prostate biopsy after a screening PSA of 10-20 ng/mL. We performed logistic regression analysis to determine associations between clinicopathologic characteristics and the outcome of interest, which was the presence of grade group (GG) ≥2 at biopsy. We examined the combined effect of PHI with MRI findings in cancer detection.

RESULTS

There were 456 patients, of whom 304 (66.7%) had cancer at biopsy. The median PHI of patients with GG ≥2 was significantly higher than those without cancer (76.3 vs 44.2, P <.001). Patients with PHI ≥55.0 demonstrated an 8.9 times (P = .001) increased odds of GG ≥2 disease than patients with PHI 0-26.9. Higher prostate imaging reporting and data system (PI-RADS) scores on MRI were associated with a significant increase in cancer detection. Cancer was diagnosed in zero patients with PHI <36 and PI-RADS 1-2 and in 1 of 22 patients (4.5%) with PHI <36 and PI-RADS 1-3.

CONCLUSION

PHI was associated with the detection of cancer among biopsy-naïve men with a screening PSA of 10-20 ng/mL. The combined use of PHI and MRI can help triage patients in lower resource settings and reduce unnecessary biopsies.