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
Wiegel T et al. - In a study to compare radical prostatectomy (RP) followed by immediate radiotherapy (RT) with RP alone for pts with pT3 prostate cancer (PCa) and an undetectable prostate-specific antigen (PSA) level after RP, it was reported that adjuvant RT for pT3 PCa with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Methods- After RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT.
- Eligible pts had pT3 pN0 tumors.
- Pts who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%).
- 34 of 307 pts on the RT arm did not receive RT and 5 pts on the wait-and-see arm received RT.
- 114 pts underwent RT and 154 pts were treated with a wait-and-see policy.
- Primary endpoint was biochemical progression-free survival (PFS).
Results- Biochemical PFS after 5 yrs in pts with undetectable PSA after RP was significantly improved in the RT group (72% vs 54%).
- On univariate analysis, Gleason score >6 and <7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome.
- Rate of grade 3 to 4 late adverse effects was 0.3%.
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