Prostate-specific antigen doubling time as a predictor of prostate cancer disease progression and survival

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4554 Background: Prostate-specific antigen doubling time (PSADT) has been identified as a predictor of outcome in prostate cancer. Atrasentan, a potent, selective, oral endothelin A receptor antagonist, significantly decreased time to prostate-specific antigen (PSA) progression in a randomized, double-blind, placebo-controlled phase 2 trial in 271 men with metastatic HRPC. In that study, PSADT <4 mo was predictive of rapid disease progression and decreased survival in men with metastatic hormone-refractory prostate cancer (HRPC). Our objective was to confirm the utility of PSADT as a predictor of disease progression and survival in a larger population of subjects from combined phase 2 and 3 trials. Methods: Data from randomized, double-blind, placebo-controlled phase 2 and 3 trials of metastatic HRPC patients given either placebo or atrasentan (10 or 2.5 mg QD) were combined. Measurements from 982 patients with a minimum of 3 PSA values on treatment were analyzed. Data from all treatment arms were pooled and stratified by PSADT <4 mo vs ≥4 mo. Kaplan-Meier and Cox proportional hazard methodologies were used to compare time to disease progression (TTP) and survival between the PSADT <4 mo and PSADT ≥4 mo groups. Results: 982 patients were included in the analyses: 484 patients had a PSADT <4 mo and 498 had a PSADT ≥4 mo. Patients with a PSADT ≥4 mo showed a statistically significant longer median TTP (178 days), more than twofold greater than those with a PSADT <4 mo (85 days, log-rank p<0.001). Survival in patients with a PSADT <4 mo was significantly shorter than that in patients with a PSADT ≥4 mo (log-rank p<0.001). Median survival was 445 days for patients with PSADT <4 mo vs 746 days for patients with PSADT ≥4 mo. Conclusions: These data confirm earlier findings that a PSADT <4 mo is predictive of early disease progression and reduced survival of men with metastatic HRPC, independent of therapy. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Abbott Laboratories Abbott Laboratories Abbott Laboratories

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