{Reference Type}: Comparative Study
{Title}: Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial.
{Author}: Wiegel T;Bartkowiak D;Bottke D;Bronner C;Steiner U;Siegmann A;Golz R;Störkel S;Willich N;Semjonow A;Stöckle M;Rübe C;Rebmann U;Kälble T;Feldmann HJ;Wirth M;Hofmann R;Engenhart-Cabillic R;Hinke A;Hinkelbein W;Miller K;
{Journal}: Eur Urol
{Volume}: 66
{Issue}: 2
{Year}: Aug 2014
{Factor}: 24.267
{DOI}: 10.1016/j.eururo.2014.03.011
{Abstract}: <B>BACKGROUND: </B>Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Three prospectively randomized trials demonstrated an advantage for adjuvant radiotherapy (ART) compared with a wait-and-see (WS) policy.<BR><B>OBJECTIVE: </B>To determine the efficiency of ART after a 10-yr follow-up in the ARO 96-02 study.<BR><B>METHODS: </B>After RP, 388 patients with pT3 pN0 prostate cancer (PCa) were randomized to WS or three-dimensional conformal ART with 60 Gy. The present analysis focuses on intent-to-treat patients who achieved an undetectable prostate-specific antigen after RP (ITT2 population)--that is, 159 WS plus 148 ART men.<BR><B>METHODS: </B>The primary end point of the study was progression-free survival (PFS) (events: biochemical recurrence, clinical recurrence, or death). Outcomes were compared by log-rank test. Cox regression analysis served to identify variables influencing the course of disease.<BR><B>CONCLUSIONS: </B>The median follow-up was 111 mo for ART and 113 mo for WS. At 10 yr, PFS was 56% for ART and 35% for WS (p<0.0001). In pT3b and R1 patients, the rates for WS even dropped to 28% and 27%, respectively. Of all 307 ITT2 patients, 15 died from PCa, and 28 died for other or unknown reasons. Neither metastasis-free survival nor overall survival was significantly improved by ART. However, the study was underpowered for these end points. The worst late sequelae in the ART cohort were one grade 3 and three grade 2 cases of bladder toxicity and two grade 2 cases of rectum toxicity. No grade 4 events occurred.<BR><B>CONCLUSIONS: </B>Compared with WS, ART reduced the risk of (biochemical) progression with a hazard ratio of 0.51 in pT3 PCa. With only one grade 3 case of late toxicity, ART was safe.<BR><B>RESULTS: </B>Precautionary radiotherapy counteracts relapse after surgery for prostate cancer with specific risk factors.