Editing Adjuvant and Salvage Radiotherapy After Prostatectomy (2019) (section)

== Adjuvant Radiotherapy ==

=== Evidence ===

*'''3 RCTs (SWOG 8794, EORTC 22911, and ARO 96-02) randomized patients with adverse pathological features at prostatectomy to ART vs. observation'''
** '''See [[Prostate Cancer: Management of Locally Advanced Prostate Cancer|Management of Locally Advanced Prostate Cancer Notes]]'''
** '''All 3 trials have > 10 years follow-up'''
** '''All 3 trials documented significant improvements in biochemical RFS with use of ART.'''
*** The Panel notes that prevention of biochemical progression is an important clinical endpoint because biochemical progression may trigger salvage therapy (i.e., hormone therapy), with its associated toxicities (increased risks for osteoporosis, cardiovascular disease and other health problems with ADT) and QoL impact. In addition, patients with biochemical recurrence are more likely to manifest metastatic recurrence. Therapies for metastatic recurrence, such as hormone therapies, can also have profound QoL impact.
** The 2 RCTs that evaluated locoregional failure (SWOG 8794; EORTC 22911) demonstrated a reduction in locoregional failure with ART
** Both SWOG 8794 and EORTC 22911 reported statistically significant reductions in the use of subsequent salvage therapies with ART
** SWOG 8794 and EORTC 22911 demonstrated improved cPFS (defined as clinical or imaging evidence of recurrence or death but not including biochemical progression) with ART
** '''2 of the trials, SWOG 8794 and EORTC 22911, assessed metastatic recurrence and OS'''. '''Only SWOG 8794 demonstrated significantly improved metastatic recurrence-free survival and overall survival;''' ARO-96-02 and EORTC were not designed to identify a significant reduction in metastasis or death with adjuvant radiotherapy
* '''Given the consistency of findings across trials regarding other clinically-important endpoints of reduced biochemical and locoregional failure, clinical progression, and the reduction in the need for initiation of salvage therapies in patients administered ART, the Panel concluded that patients with high-risk pathological features should be offered ART.'''

=== Benefits ===

* '''Patients with adverse pathologic findings should be informed that compared to RP only, ART:'''
** '''Reduces the risk of biochemical recurrence, local recurrence, and clinical progression of cancer'''
** '''Impact on subsequent metastases and overall survival is less clear'''

=== Indications ===
*'''<span style="color:#ff0000">Should be offered to patients with adverse pathologic findings at prostatectomy (3):'''
*#'''<span style="color:#ff0000">Extraprostatic extension'''
*#'''<span style="color:#ff0000">Seminal vesicle invasion'''
*#'''<span style="color:#ff0000">Positive surgical margins'''
*'''By “offered,” the Panel means that the patient, his family and the multi-disciplinary treatment team should engage in a shared decision-making process in which the patient is advised to consider the possibility of additional treatment (i.e. RT).'''

=== Timing ===
*'''<span style="color:#ff0000">ART is usually administered within 4-6 months following RP, generally after the return of acceptable urinary control'''
** As sexual function can require 1-2 years before a full return of function is observed, '''return of erections is not a requirement before initiation of adjuvant radiation.'''

=== ADT ===
*'''The role of hormone therapy in addition to ART remains uncertain'''
** This will be addressed in the RADICALS trial