The primary endpoint, '%PSADT > 2y', did not meet the pre-specified decision criteria. Further prospective study with revised program and endpoint is needed.

No abstract

The objective of this study was to better understand the implications of the rate of prostate-speci®c antigen (PSA) changes in prostate carcinoma. We retrospectively calculated PSA doubling times prior to surgery in 62 patients with prostate carcinoma. The calculated values were compared with ®nal pathologic ®ndings and with rates of PSA failure after surgery. PSA values increased during the period of observation in 82.3% of the patients, whereas 17.7% had levels that remained stable. The median calculated PSA doubling time in those with increasing levels was 25.8 months, with doubling times 24 months observed in 37.1% of the patients. Stage pT3 disease was more common in patients with PSA doubling times of 36 months than in those with doubling times b 36 months (P 0.02). Biochemical failure was more common in patients with rapid PSA doubling times (P`0.01). The calculated PSA doubling time prior to radical surgery is signi®cantly associated with the ®nal pathologic ®ndings. Early PSA failure is more common in patients with rapid PSA doubling times prior to radical surgery. Prostate Cancer and Prostatic Diseases (2000) 3, 269±274.

Background:In order to define the characteristics of patients with clinical stage T I c prostate cancer in lapan, clinicopathologic data obtained from patients treated by radical prostatectomy were reviewed. Methods: Fifty-four stage T1 c cancers were evaluated for tumor volume, Cleason grade, tumor location and pathologic stage from prostatectomy specimens in association with preoperative clinical parameters. Results:The mean tumor volume was 3.94 mL (range, 0.07 to 33.4 mL), and 1 1 of the 54 tumors had a tumor volume of less than 0.5 mL. Thirty-two tumors (59%) were organ-confined, while 7 (1 3%) involved the seminal vesicle and/or regional lymph nodes. Multivariate logistic regression analysis of the pretreatment variables, including age, pretreatment PSA level, prostate volume, biopsy grade, and number of cancer-positive cores revealed that the serum PSA level and the number of cancer-positive biopsy cores were independent factors to predict organ-confined tumors ( P = 0.036 and 0.044, respectively). For T1 c cancer with less than 4 cancer-positive biopsy cores, the sensitivity and specificity for predicting organconfined tumors were 90% and 70%, with a cut-off value of 17 n g h L for the serum PSA level. Conclusion:The clinicopathologic features of T1 c prostate cancer in Japanese patients were similar to those of whites reported elsewhere. Both serum PSA levels and the number of positive biopsy cores may be useful as pretreatment parameters to identify patients with the potential to benefit from radical treatment.Int J Urol 1998;5:454-458

No abstract