BACKGROUND: Approximately 30% to 50% of clinically localized prostate cancers are found to be locally advanced after radical prostatectomy. Without adjuvant therapy, more than 30% of stage pT3 patients will have biochemical failure in a median follow-up of three years. Whether adjuvant therapy should be given remains controversial. Identification of prognostic indicators may be helpful to select patients at risk of biochemical failure for postoperative adjuvant therapy. METHODS: The medical records of 22 pT3 prostate cancer patients were analyzed retrospectively. Postoperative management included surveillance (7 patients), adjuvant hormone therapy (7) and radiotherapy (8). Patients were monitored every three months using serum prostate-specific antigen (PSA). Biochemical failure was defined as an elevation in PSA of more than 0.2 ng/ml. The clinical outcome was correlated with tumor grading, pathologic staging, preoperative PSA level, and p53 and bcl-2 status. RESULTS: Five patients (23%) experienced biochemical relapse within a median follow-up time of 52 months (range, 10-71 months). A Gleason score of 8 or more (p = 0.001) and seminal vesicle involvement (p = 0.014) were significant prognostic indicators in the univariate analysis. Patients with low preoperative PSA levels (< 20 ng/ml) had a significantly higher failure rate (p = 0.031). However, most of these patients (56%) had tumors with Gleason scores of 8 or more. Neither p53 gene mutation nor bcl-2 overexpression predicted PSA failure. Postoperative adjuvant therapy did not appear to reduce the risk of disease recurrence. In multivariate analysis, the Gleason score was the only significant factor predicting biochemical failure (p = 0.017). CONCLUSIONS: Patients with poorly differentiated tumors and/or seminal vesicle invasiveness are at higher risk of biochemical failure after radical prostatectomy. Our limited experience did not support the routine application of adjuvant therapy for this subgroup of patients. A larger sample size with a longer follow-up period is necessary to reach a definitive conclusion. ref.: Zhonghua Yi Xue Za Zhi (Taipei). 2000 Feb;63(2):124-30.