Introduction and Objective: We assessed a novel application of the Prostate Health Index [Phi = (proPSA / free PSA) × (square root of PSA)] developed by Beckman-Coulter Inc. and DNA content measurements in benign-adjacent and cancer tissue areas to predict which patients would eventually require treatment for prostate cancer (PCa) in an active surveillance (AS) cohort.

Methods: We identified 71 men at the Johns Hopkins Hospital AS program which had banked serum from the time of diagnosis available for the study. 39 developed an unfavorable biopsy (Gleason score >6, Gleason pattern 4/5, >2 cores positive for cancer, >50% of any core involved with cancer), while 32 have maintained favorable biopsies (median follow-up: 3.7 years). Serum total PSA, free PSA and [−2] proPSA were measured by the Beckman Coulter immunoassay. DNA content measurements of Feulgen-stained biopsy sections were performed with the AutoCyteTM imaging system. Cox proportional hazard regression and Kaplan-Meier plots were used to identify significant prognosticators for unfavorable biopsy conversion-free survival.

Results: The ratio of Phi in serum was significantly higher (37.23 ± 15.76 vs. 30.60 ± 12.70 p=0.03) in men ultimately developing unfavorable biopsies. Serum Phi [HR(95%CI): 2.39 (1.26-4.52), p=0.007], BA excess of optical density (OD) [HR (95%CI): 2.58 (1.17-5.68), p=0.019] and CA standard deviation of OD [HR (95%CI): 5.36 (1.89-15.24), p=0.002] were significant predictors of an unfavorable biopsy conversion in both Kaplan-Meier and Cox regression analysis. Patients with Phi >34.2 and CA standard deviation of OD >4.0 showed the highest risk for unfavorable biopsy conversion (p<0.0001).

Conclusions: Measurement of the serum Phi and tissue DNA content at the time of diagnosis are able to predict which men enrolled in an AS cohort will ultimately require treatment for PCa.

Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 101st Annual Meeting of the American Association for Cancer Research; 2010 Apr 17-21; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2010;70(8 Suppl):Abstract nr 2731.