Incorporating Prostate Health Index Density, MRI, and Prior Negative Biopsy Status to Improve the Detection of Clinically Significant Prostate Cancer
We determined the performance of Prostate Health Index (PHI) density (PHID) combined with MRI and prior negative biopsy (PNB) status for the diagnosis of clinically-significant prostate cancer (CSPCa).
Patients without a prior diagnosis of PCa, with elevated PSA and a normal DRE who had PHI testing prospectively prior to prostate biopsy were included. PHID was calculated using prostate volume. Univariable and multivariable logistic regression modeling, along with receiver operating characteristic analysis, was used to determine the ability of serum biomarkers to predict CSPCa (Grade group (GG) ≥2 or GG1 PCa detected in >2 cores or >50% of any one core) on biopsy. Age, PNB status and PIRADS score were incorporated into the regression models.
Of the 241 men who qualified for the study, 91 (37.8%) had CSPCa on biopsy. The median PHID was 0.74 (IQR 0.44-1.24); it was 1.18 (IQR 0.77-1.83) and 0.55 (IQR 0.38-0.89) in those with and without CSPCa on biopsy, respectively (p
In this contemporary cohort of men undergoing prostate biopsy for the diagnosis of PCa, PHID outperformed PHI and other PSA-derivatives for the diagnosis of CSPCa. Incorporating age, PNB status, and PIRADS score led to even further gains in the diagnostic performance of PHID. Furthermore, PIRADS score was found to be complementary to PHID. Using 0.44 as a cutoff for PHID, 35.3% of unnecessary biopsies could have been avoided at the cost of missing 7.7% of CSPCa. Despite these encouraging results, prospective validation is needed.
Funding: A.E.R. is supported by a DOD PRTA award (W81XWH-13-1-0445) as well as a PCF Young Investigator Award and Patrick C. Walsh Investigator Grant.