Abstract
48 Background: There are limited data regarding practice patterns and outcomes among patients with a very high prostate-specific antigen (PSA) level ( > = 98.0 ng/mL) but clinically localized (N0M0) prostate cancer. Methods: We used the National Cancer Database (NCDB) to identify 748,825 patients with prostate cancer diagnosed 2004-2012. We subdivided these patients by PSA level (0-9.9, 10-19.9, 20-39.9, 40-59.9, 60-79.9, 80-97.9, and > = 98.0 ng/mL), nodal status (N0 vs N1) and the presence of distant metastases (M0 vs M1). We determined the rate of definitive LR therapy (pelvic and/or prostate radiation and/or radical prostatectomy) in each group. Overall survival was compared using Cox multivariable regression modeling after adjusting for patient race, income quartile, education quartile, age, and year of diagnosis. Results: Rates of definitive LR therapy for patients with PSA > = 98.0 ng/mL and N0M0 disease were significantly lower than they were for those with N1M0 disease (52.6% vs 60.4%, p < 0.001) or with PSA < 98.0 ng/mL and N0M0 disease (52.6% vs 86.6%, p < 0.001). Among patients with N0M0 disease, 5-year OS decreased with increasing PSA: for PSA levels of 0-9.9, 10-19.9, 20-39.9, 40-59.9, 60-79.9, 80-97.9, and > = 98.0 ng/mL, 5-year OS was 91.6%, 84.3%, 80.2%, 84.1%, 81.8%, 80.2%, and 59.1%, respectively. Among those with N1M0 disease, 5-year OS was 63.2%, which in multivariable Cox regression modeling was not significantly different compared to those with PSA > = 98.0 ng/mL N0M0 disease (adjusted hazard ratio [AHR] 0.99, 95% confidence interval 0.91-1.09, p = 0.942). The survival benefit associated with LR treatment was larger among those with N0M0 high-PSA disease than among those with N1M0 disease (AHR of 0.26 vs 0.41, p-interaction < 0.001). Conclusions: Patients with clinically N0M0 disease but very high PSA ( > = 98.0 ng/mL) have similar outcomes as patients with N1 disease but receive definitive LR therapy at a lower rate. It is possible that patients with N0M0 disease and PSA > = 98.0 ng/mL represent a population that should be treated as more similar to the N1M0 population, rather than the M1 population, including consideration of LR therapy in appropriate contexts.
