PR07

A randomised trial of hormone therapy plus radical radiotherapy versus hormone therapy alone in non-metastatic prostate cancer

Adding radiotherapy to hormone therapy improves survival of men with locally-advanced prostate cancer

What was this study about?

The PR07 trial was conducted as a collaboration between the MRC CTU and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG). The trial closed to recruitment in 2005 with over 1200 patients; patients remain on follow up. The aim of the trial was to evaluate whether there was a benefit from the addition of external beam radiation therapy to the treatment of patients with non-metastatic prostate cancer who have not had a radical prostatectomy and are receiving hormonal therapy.

What difference did this study make?

We found clear evidence that adding radiotherapy to hormone therapy improved survival for men with locally advanced prostate cancer. Hormone therapy comes with well-known side-effects but is tolerable for most men. Radiotherapy added some side-effects, as expected, but these were considered acceptable.

Practice started to change towards combining hormone therapy and radiotherapy after interim trial data were released. These data were complemented by a similar Scandinavian trial which also showed a survival advantage in adding radiotherapy to hormone therapy.

We have now presented long-term follow-up data which confirms the advantage in survival. We know that not all practitioners are routinely offering combined hormone therapy and radiotherapy; these data should change this. The combined treatment will provide men with prostate cancer tens of thousands of additional life-years, globally.

The data have also had an impact on our other trials. The backbone of care in both STAMPEDE and PATCH was updated to mandate radiotherapy with long-term hormone therapy in the population overlapping with PR07. These trials also encourage radiotherapy in men whose cancer has spread to regional lymph nodes. This has been investigated in a non-randomised comparison in STAMPEDE and shown to have a good effect on biochemical failure-free survival; further follow-up is required. The findings of PR07 also led, indirectly, to the "M1|RT comparison" in STAMPEDE in which men whose newly-diagnosed prostate cancer has already spread to distant sites are randomised to receive radiotherapy to the prostate in addition to standard long-term hormone therapy or to continue standard care.