DESIGN, SETTING, AND PARTICIPANTS: 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: 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. RESULTS AND LIMITATIONS: 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.
zurück Home ARO 96-02, AUO AP09/95
Fragestellung Kann eine postoperative Bestrahlung bei T3-Prostata - Tumoren ohne nachweisbaren PSA-Spiegel das Ergebnis verbessern?
Ergebnis Eine postoperative Bestrahlung bei T3-Tumoren reduziert das Risiko eines biochemischen Rezidivs.
5a ohne PSA-Rezidiv mit RT ohne RT p
72% 54% 0,0015

Prognosefaktoren

Gleason >6, praeoperatives PSA, Stadium, Resektionsränder
Behandlungs-Arm radikale Prostatektomie und Nachbestrahlung
Kontrollarm radikale Prostatektomie ohne Bestrahlung

Einschluss

  • 307 Männer
  • pT3 pNo
  • postoperativ kein PSA nachweisbar
Quelle 1.) Wiegel T, et al.:
Phase III postoperative adjuvant radiotherapy after radical prostatectomy
compared with radical prostaectomy alone in pT3 prostatic cancer with postoperative undetectable prostate-specific antigen.
ARO 96-02 / AUO AP 09/95.
JCO 27(2009): 2924-30

2.) Wiegel T, et al.:
Adjuvant radiotherapy versus wait-and-see after radical prostatectomy: 10-year follow-up of the ARO 96-02/AUO AP 09/95 trial.
Eur Urol 2014;66:243-50.
Doi: 10.1016/j.eururo.2014.03.011.

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