PROSTATE-SPECIFIC ANTIGEN FAILURE DESPITE PATHOLOGICALLY ORGAN-CONFINED AND MARGIN-NEGATIVE PROSTATE-CANCER - THE BASIS FOR AN ADJUVANT THERAPY TRIAL

Purpose: A multivariable analysis to evaluate the potential clinical a nd pathologic factors that predict for early biochemical failure in pa tients with pathologically organ-confined and margin-negative disease was performed to define patients who may benefit from adjuvant therapy . Patients and Methods: Three hundred forty-one prostate cancer patien ts treated with a radical retropubic prostatectomy between January 198 9 and June 1995 and found to have pathologically organ-confined and ma rgin-negative disease comprised the study population. A logistic regre ssion multivariable analysis to evaluate the predictive value of the p reoperative prostate-specific antigen (PSA) level, pathologic (prostat ectomy) Gleason score, and pathologic stage on PSA failure occurring d uring the first postoperative year was performed. Results: Predictors of PSA failure during the first postoperative year in patients with pa thologically organ-confined disease included pathologic Gleason score greater than or equal to 7 (P = .0007) and preoperative PSA level grea ter than 10 (P < .0001). Corresponding 3-year freedom-from-PSA-failure rates for these pathologic organ-confined patients with both, one, or neither of these factors were 60%, 75% to 84%, and 95%, respectively (P < .0001). Conclusion: Prostate cancer patients with pathologically organ-confined and margin-negative disease and a preoperative PSA leve l greater than 10 ng/mL or a pathologic Gleason score greater than or equal to 7 have significant decrements in short-term PSA-failure-free survival. Therefore, these patients should be considered for adjuvant therapy in the setting of a phase III clinical trial. (C) 1997 by Amer ican Society of Clinical Oncology.