Originally published as JCO Early Release 10.1200/JCO.2008.18.9563 on May 11 2009

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Phase III Postoperative Adjuvant Radiotherapy After Radical Prostatectomy Compared With Radical Prostatectomy Alone in pT3 Prostate Cancer With Postoperative Undetectable Prostate-Specific Antigen: ARO 96-02/AUO AP 09/95

From the Department of Radiation Oncology, University Hospital Ulm, Ulm; Departments of Urology and Radiation Oncology, Charité Universitätsmedizin, Campus Benjamin-Franklin, Berlin; Department of Pathology, Helios-Clinic Wuppertal, Wuppertal; Departments of Radiation Oncology and Urology, University Hospital Münster, Münster; Department of Radiation Oncology, General Hospital Hagen, Hagen; Departments of Urology and Radiation Oncology, University Hospital Homburg/Saar, Homburg/Saar; Department of Urology, Euro-Med-Clinic Fürth, Fürth; Department of Urology, General Hospital Berlin-Herzberge, Berlin-Herzberge; Department of Urology, Diakonissinnen-Krankenhaus Dessau, Dessau; Departments of Urology and Radiation Oncology, General Hospital Fulda, Fulda; Department of Urology, University Hospital Dresden, Dresden; and WiSP GmbH, Langenfeld, Germany.

Corresponding author: Thomas Wiegel, MD, Department of Radio Oncology, University Hospital Ulm, Albert-Einstein-Allee 23, D-89081 Ulm, Germany; e-mail: thomas.wiegel{at}uniklinik-ulm.de.

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.

Supported by a grant of the "Deutsche Krebshilfe-Mildred Scheel Stiftung" (Grant No. 70-2293).

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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