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. - Adjuvant radiotherapy (RT) for pT3 prostate cancer with postoperatively undetectable PSA significantly reduces the risk of biochemical progression. Further follow-up is needed to assess the effect on metastases-free and overall survival. Methods- Study to compare radical prostatectomy (RP) followed by immediate RT for pts with pT3 PCa and an undetectable PSA after RP
- Eligible pts had pT3 pN0 tumors; after RP:
- 192 men were randomly assigned to a wait-and-see policy, and
- 193 men were assigned to immediate postoperative RT
- Pts who did not achieve an undetectable PSA after RP were excluded
- Of the remaining 307 pts, 34 pts on the RT arm did not receive RT and 5 pts on the wait-and-see arm received RT
- Therefore, 114 pts underwent RT and 154 pts were treated with a wait-and-see policy
- The primary end point: 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
- 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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