1: 10-yr survival is the same for men following active monitoring, surgery or radiotherapy
The ProtecT trial, published this month in the New England Journal of Medicine, has reported that men with localised prostate cancer who participated in ‘active monitoring’ had the same 10 year survival as men who had either radical prostatectomy or external-beam radiotherapy. 1643 men were randomised to the three treatment arms and followed for a median of 10 years; by the end of the study approximately 50% of men assigned to active monitoring had undergone either surgery or radiotherapy as their disease progressed. There was no difference in prostate cancer specific survival between any of the arms. However as survival was very high (over 98.8%) in all three groups it will be important to see the results of the planned follow up in 5 years, to see if any of the treatments affect mortality at later time periods. Most of the men who took part in the trial had low risk disease (median PSA 4.6 ng/mL, 77% had Gleason 6) and if currently diagnosed would already be encouraged to undergo active surveillance. This trial did not include enough men with higher-risk localised disease (i.e. Gleason 7) to draw a conclusion about the effectiveness of active monitoring for men in this risk category.
Despite having similar survival, men who were on the active monitoring arm had higher rates of disease progression (112 men in the active monitoring, 46 men in the surgery and 46 men in the radiotherapy group, p<0.001) and metastatic disease (33 men in the active monitoring, 13 men in the surgery and 16 men in the radiotherapy group, p<0.004). During the trial, men in active monitoring were followed by PSA kinetics. This is quite different than current active surveillance protocols, which recommend including mpMRI staging and scheduled repeat biopsies, and it is likely that this more active method may result in decreased rates of disease progression for men currently under active surveillance protocols.
When taken together with the patient-reported outcomes (published concurrently and described below) this study supports the use of active monitoring for men with localised prostate cancer and will help men make a more informed treatment choice that is right for them.