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Randomized Controlled Trial
. 2009 Mar;181(3):956-62.
doi: 10.1016/j.juro.2008.11.032. Epub 2009 Jan 23.

Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial

Affiliations
Randomized Controlled Trial

Adjuvant radiotherapy for pathological T3N0M0 prostate cancer significantly reduces risk of metastases and improves survival: long-term followup of a randomized clinical trial

Ian M Thompson et al. J Urol. 2009 Mar.

Abstract

Purpose: 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.

Materials and 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.

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Figures

Fig. 1
Fig. 1
Metastasis Free Survival by Treatment Arm
Fig. 2
Fig. 2
Survival by Treatment Arm
Fig. 3
Fig. 3
Metastasis-Free Survival Hazard Ratio Estimates and Corresponding 95% Confidence Intervals for Subsets of Patients Based on Baseline Risk Factors
Fig. 4
Fig. 4
Metastasis Free Survival For Radiotherapy Arm Stratified by PSA Status After Prostatectomy

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