医学
前列腺切除术
前列腺癌
泌尿科
前列腺特异性抗原
危险系数
临床终点
随机对照试验
前列腺
放射治疗
单变量分析
癌症
外科
内科学
多元分析
置信区间
作者
Thomas Wiegel,Dirk Bottke,Ursula Steiner,Alessandra Siegmann,Reinhard Golz,Stephan Störkel,N. Willich,Axel Semjonow,Rainer Souchon,Michael Stöckle,Christian Rübe,L. Weißbach,P Althaus,U. Rebmann,T. Kälble,Horst Jürgen Feldmann,Manfred P. Wirth,Axel Hinke,W. Hinkelbein,Kurt Miller
标识
DOI:10.1200/jco.2008.18.9563
摘要
Purpose Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP. Methods After RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival. Results Biochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%. Conclusion Adjuvant RT for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival.
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