STAGE T1-2 PROSTATE-CANCER WITH PRETREATMENT PROSTATE-SPECIFIC ANTIGEN LEVEL LESS-THAN-OR-EQUAL-TO-10 NG ML - RADIATION-THERAPY OR SURGERY/

Purpose: To detect differences in biochemical failure rates by treatme nt modality (radiation therapy or radical prostatectomy) in patients w ith early-stage prostate cancer presenting with pretreatment prostatic -specific antigen (PSA) levels less than or equal to 10.0 ng/ml. Metho ds and Materials: A total of 1467 consecutive patients with prostate c arcinoma were treated with either radiotherapy (RT) or radical prostat ectomy (RP) between January 1987 and June 1996. Patients with the foll owing were excluded from the present study: initial PSA (iPSA) level > 10 ng/ml (n = 444), clinical Stage T3 disease (n = 73), adjuvant or n eoadjuvant treatment (n = 173), no available iPSA level (n = 31), no a vailable biopsy Gleason score (GS) (n = 33), incomplete pathologic inf ormation (n = 16), and no available follow-up PSA levels (n = 90). The analysis was performed on 607 cases: 354 treated with RP and 253 with RT (median dose 68.4 Gy). The outcome of interest was biochemical rel apse-free survival (bRFS), with biochemical relapse being defined as e ither a detectable PSA level after RP or elevation in PSA levels of gr eater than or equal to 1.0 ng/ml above the nadir after RT. Proportiona l hazards were used to analyze the effect of treatment modality and co nfounding variables (i.e., age, stage, biopsy GS, iPSA levels) on trea tment outcome. Results: Seventy-nine percent of patients (n = 478) had clinical Stage T1 or T2A disease at presentation (RP vs. RT: 84% vs. 71%, p < 0.001). Twenty one percent of patients (n = 127) had iPSA lev els less than or equal to 4 ng/ml ((RP vs. RT: 24% vs. 17%, p = 0.027) . Seventy-six percent of patients (n = 460) had biopsy GS less than or equal to 6 (RP vs. RT: 79% vs. 71%, p = 0.014). The median follow-up time was 24 months (range 3-110). For the 607 patients, the 5-year bRF S rate was 76%. The 5-year RFS rates for RP versus RT were 76% versus 75%, respectively (p = 0.09). After adjustment for all confounding var iables, iPSA levels (p < 0.001) and biopsy GS (p = 0.001) were the onl y independent predictors of relapse, whereas age, clinical stage, and treatment modality were not (p = 0.20; p = 0.09; and p = 0.10, respect ively). Conclusion: In patients with clinical Stage T1-2 prostate canc er and pretreatment PSA less than or equal to 10 ng/ml, there is no di fference in biochemical failure rates between those treated with radia tion and those treated with surgery. (C) 1997 Elsevier Science Inc.