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

Area of Science:

• Urology
• Oncology
• Medical Diagnostics

Background:

• Elevated Prostate-Specific Antigen (PSA) levels (10-20 ng/mL) in biopsy-naïve men often necessitate further investigation for prostate cancer.
• Distinguishing clinically significant prostate cancer from indolent disease is crucial for appropriate patient management.

Purpose of the Study:

• To evaluate the diagnostic performance of the Prostate Health Index (PHI) in identifying clinically significant prostate cancer (Grade Group ≥2) among biopsy-naïve men with PSA levels between 10-20 ng/mL.
• To assess the added value of combining PHI with Magnetic Resonance Imaging (MRI) findings for prostate cancer detection.

Main Methods:

• A cohort of 456 biopsy-naïve men with PSA 10-20 ng/mL underwent PHI testing and prostate biopsy.
• Logistic regression analysis was used to correlate clinicopathologic characteristics, including PHI and MRI PI-RADS scores, with the presence of Grade Group (GG) ≥2 cancer.
• The combined predictive value of PHI and MRI was examined.

Main Results:

• Of 456 patients, 304 (66.7%) were diagnosed with cancer at biopsy.
• Median PHI was significantly higher in patients with GG ≥2 cancer (76.3) compared to those without (44.2, P<0.001).
• PHI ≥55.0 was associated with an 8.9-fold increased odds of GG ≥2 disease (P=0.001). Higher PI-RADS scores also correlated with increased cancer detection. Notably, no cancer was detected in patients with PHI <36 and PI-RADS 1-2.

Conclusions:

• PHI is a valuable biomarker for detecting clinically significant prostate cancer in men with intermediate PSA levels (10-20 ng/mL).
• The integration of PHI and MRI offers a synergistic approach to enhance cancer detection accuracy.
• This combined strategy holds potential for optimizing patient triage, particularly in resource-limited settings, thereby reducing the rate of unnecessary prostate biopsies.