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.
OBJECTIVE
Local failure after radical prostatectomy (RP) is common in patients with cancer extending beyond the capsule. Two randomized trials demonstrated an advantage for adjuvant radiotherapy (RT) compared with a wait-and-see policy. We conducted a randomized, controlled clinical trial to compare RP followed by immediate RT with RP alone for patients with pT3 prostate cancer and an undetectable prostate-specific antigen (PSA) level after RP.


METHODS
After RP, 192 men were randomly assigned to a wait-and-see policy, and 193 men were assigned to immediate postoperative RT. Eligible patients had pT3 pN0 tumors. Patients who did not achieve an undetectable PSA after RP were excluded from treatment according to random assignment (n = 78; 20%). Of the remaining 307 patients, 34 patients on the RT arm did not receive RT and five patients on the wait-and-see arm received RT. Therefore, 114 patients underwent RT and 154 patients were treated with a wait-and-see policy. The primary end point was biochemical progression-free survival.


RESULTS
Biochemical progression-free survival after 5 years in patients with undetectable PSA after RP was significantly improved in the RT group (72%; 95% CI, 65% to 81%; v 54%, 95% CI, 45% to 63%; hazard ratio = 0.53; 95% CI, 0.37 to 0.79; P = .0015). On univariate analysis, Gleason score more than 6 and less than 7, PSA before RP, tumor stage, and positive surgical margins were predictors of outcome. The rate of grade 3 to 4 late adverse effects was 0.3%.


CONCLUSIONS
Adjuvant 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.
Department of Radio Oncology, University Hospital Ulm, Ulm, Germany. thomas.wiegel@uniklinik-ulm.de
Thomas
T
Wiegel
Dirk
D
Bottke
Ursula
U
Steiner
Alessandra
A
Siegmann
Reinhard
R
Golz
Stephan
S
Störkel
Norman
N
Willich
Axel
A
Semjonow
Rainer
R
Souchon
Michael
M
Stöckle
Christian
C
Rübe
Lothar
L
Weissbach
Peter
P
Althaus
Udo
U
Rebmann
Tilman
T
Kälble
Horst Jürgen
HJ
Feldmann
Manfred
M
Wirth
Axel
A
Hinke
Wolfgang
W
Hinkelbein
Kurt
K
Miller
D000368:Aged; D018450:Disease Progression; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000401:mortality / Q000628:therapy*; D018714:Radiotherapy, Adjuvant
D017430:Prostate-Specific Antigen