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.
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allgemeines Gemeinschaftsprojekt der Schweizer Arbeitsgemeinschaft für klinische Krebsforschung und der GTCSC (BRD)
Fragestellung  De-Eskalation beim Seminom IIA/B möglich?
Ergebnis Studie rekrutiert noch.

Prognosefaktoren

  
Chemotherapie 1x Carboplatin AUC7, dann RT
RT IIA: 30Gy/ ED 2Gy betroffener Knoten IIB: 36Gy/ ED 2Gy betroffener Knoten

Einschluss
  • Seminom
  • Stadium II A/B
  • primäre inguinale Orchiektomie oder
  • Rezidiv nach aktiver Survaillannce pT1-4 cN1-2 Mo

Teil von

 Hoden-Karzinom Tumoren endokriner Organe urologische Tumoren Onkologie
Quelle 1.) , et al.:



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