The evidence supporting this protocol is provided by three RCT’s comparing Post operative RT or a wait and see policy after radical prostatectomy.
In the EORTC trial 22911 between 1992 and 2001, Bolla et alr randomly assigned men to post-operative irradiation (RT, n=502) or observation/wait and see policy (WS, n=503). After a median follow up of 10.6 years, post-operative RT significantly improved biochemical PFS where 39.4% of the RT group had biochemical or clinical progression or died compared with 61.8% in the WS group [HR 0.49; CI p<0.0001]. Locoregional control was significantly better with RT than with WS group (HR 0.45 p<0.0001) and the 10 year cumulative rate of locoregional relapse was 16.6% vs 7.3% in the RT vs WS groups respectively.
The SWOG 8794 trialr also reported significant improvements in the median PSA relapse free survival of 10.3 years vs 3.1 years for RT and observation respectively (HR 0.43 p<0.001) after a median follow up of 10.6 years. Median disease recurrence free survival 13.8 years for RT vs 9.9 years for observation (HR 0.62; p<0.001). While there was a trend to improved metastasis free survival, this was not statistically significant.
At the 10 year follow up, the ARO 96-02 trialr patients were randomised to Adjuvant RT of 60Gy/30# (n=148) compared with a wait and see policy (n=159). Superior PFS outcomes for Adjuvant RT (56%) vs a wait and see policy (35%) p<0.0001 were demonstrated. Overall survival and metastases free survival was not significant improved by Adjuvant RT.
Currently the RAVES trial (TROG 08.03),r a phase III multicentre randomised trial is underway (accrual closed late 2015) comparing adjuvant radiotherapy (RT) with early salvage RT in patients with positive margins or extraprostatic disease following RP.
Biochemical progression free survival
Bolla et al 2012r