Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial.
OBJECTIVE
Extraprostatic disease will be manifest in a third of men after radical prostatectomy. We present the long-term followup of a randomized clinical trial of radiotherapy to reduce the risk of subsequent metastatic disease and death.


METHODS
A total of 431 men with pT3N0M0 prostate cancer were randomized to 60 to 64 Gy adjuvant radiotherapy or observation. The primary study end point was metastasis-free survival.


RESULTS
Of 425 eligible men 211 were randomized to observation and 214 to adjuvant radiation. Of those men under observation 70 ultimately received radiotherapy. Metastasis-free survival was significantly greater with radiotherapy (93 of 214 events on the radiotherapy arm vs 114 of 211 events on observation; HR 0.71; 95% CI 0.54, 0.94; p = 0.016). Survival improved significantly with adjuvant radiation (88 deaths of 214 on the radiotherapy arm vs 110 deaths of 211 on observation; HR 0.72; 95% CI 0.55, 0.96; p = 0.023).


CONCLUSIONS
Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0 prostate cancer significantly reduces the risk of metastasis and increases survival.
Thompson
Ian M
IM
University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Tangen
Catherine M
CM
Paradelo
Jorge
J
Lucia
M Scott
MS
Miller
Gary
G
Troyer
Dean
D
Messing
Edward
E
Forman
Jeffrey
J
Chin
Joseph
J
Swanson
Gregory
G
Canby-Hagino
Edith
E
Crawford
E David
ED
D000368:Aged; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology* / Q000532:radiotherapy* / Q000601:surgery; D018714:Radiotherapy, Adjuvant; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors