Phase III results of adjuvant radiotherapy (RT) versus wait-and-see (WS) in patients with pT3 prostate cancer following radical prostatectomy (RP)(ARO 96-02/AUO AP 09/95): Ten years follow-up.

Genitourinary Cancer
Session Type and Session Title: 
General Poster Session A: Prostate Cancer
Oral Abstract Session A: Prostate Cancer (eQ&A)
Abstract Number: 
J Clin Oncol 31, 2013 (suppl 6; abstr 4)
Thomas Wiegel, Dirk Bottke, Detlef Bartkowiak, Claudia Bronner, Ursula Steiner, Alessandra Siegmann, Reinhard Golz, Stephan Störkel, Normann Willich, Axel Semjonow, Michael Stöckle, Christian Rübe, Peter Althaus, Udo Rebmann, Tilman Kälble, Horst J Feldmann, Manfred Wirth, Axel Hinke, Wolfgang Hinkelbein, Kurt Miller; University of Ulm, Ulm, Germany; Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany; Charité-Universitätsmedizin Berlin, Berlin, Germany; Radiation Oncology, Charité Universitätsmedizin, Berlin, Germany; Department of Pathology, Helios-Clinic Wuppertal, Wuppertal, Germany; Department of Radiation Oncology, University Hospital Münster, Münster, Germany; Department of Radiation Urology, University Hospital Münster, Münster, Germany; Department of Urology, Saarland University, Homburg, Germany; Department of Radiation Oncology, University Hospital Homburg/Saar, Homburg/Saar, Germany; Department of Urology, General Hospital Berlin-Herzberge, Berlin, Germany; Department of Urology, Diakonissinnen-Krankenhaus Dessau, Dessau, Germany; Department of Urology, General Hospital Fulda, Fulda, Germany; Department of Radiation Oncology, General Hospital Fulda, Fulda, Germany; University Hospital Carl Gustav Carus, Dresden, Germany; WisP Clinical Research Organisation, Langenfeld, Germany; Department of Hematology and Oncology, Charite Campus Benjamin Franklin, Berlin, Germany

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Abstract Disclosures


Background: Adjuvant RT for pT3 R1 or R0 patients (pts.) after RP remains controversial. The EORTC-phase-III- study suggested a 20% better biochemical control (bNED) after 10 years for RT but no survival advantage. In contrast, the SWOG trial stated not only a gain in bNED but also an improved metastasis free and overall survival after 12 years follow-up. Now, 10-years results from the ARO 96-02 study are available, which are based on the most precisely defined cohort among the three trials. Methods: 385 men with prostate cancer were randomized to either 60 Gy RT (arm A; n=193) or WS (arm B; n=192) before achieving an undetectable PSA. Pts. were stratified for Gleason-score, margin status, neoadjuvant hormonal treatment and stage (pT3a+b vs. c). When the undetectable PSA-level after RP was not achieved, progressive disease was stated and the pts. left arm A/B. Data analysis was by intent-to-treat (ITT). PSA-progression for pts. with undetectable post-RP PSA was defined as two consecutive increasing PSA. The primary endpoint was bNED. The study was powered to demonstrate a 15% increase in bNED for RT. Results: 78 pts. (20%) did not achieve an undetectable PSA and were stated as progressive disease (arm A: 45 pts., arm B: 33 pts.). Additionally, 34 pts. (23%) from the RT-arm did not receive RT. Therefore, 114 pts. had RT (arm A) and 159 pts. WS (arm B). Median follow up was 111.3 months for arm A and 113.3 months for arm B . bNED at 10 years increased to 56% for arm A (RT) compared with 35% for arm B (WS) (hazard ratio= 0.51; p = 0.00002. Out of 307 ITT pts., 15 died from prostate cancer, 23 for other and 5 for unknown reasons. There was no significant profit from ART regarding the endpoints metastasis-free survival (p=0.56) or overall survival (p=0.59). Worst late side effects to the rectum were two grade 2 cases after ART. Grade ≥2 bladder toxicity occurred in 4 out of 148 ITT pts. No grade 4 events were reported. Conclusions: With only one grade 3 case of late toxicity, ART was safe in pT3 prostate cancer. At 10 years median follow up, it reduced the risk of bNED by 49%. The study was not powered to detect differences in OS. Clinical trial information: ARO 96-02/AUO AP 09/95.