There is quite a discussion in prostate cancer for some time now if patients with limited metastatic disease, so they get diagnosed and the prostate cancer has spread to the bones in a limited fashion, normally 1-3 or even up to 5 spots, if these patients benefit from local treatment. Classically you can do this with radiotherapy or with radical prostatectomy; both surgery or radiotherapy are established treatments for prostate cancer and that’s where we come from. For many diseases we know that treatment of the primary tumour improves cancer control outcomes and we were wondering if this was also true for radical prostatectomy. That’s why we initiated the RAMPP trial.
What did you do?
We randomised patients with oligometastatic prostate cancer. They were diagnosed with oligometastatic cancer in the beginning, they were staged by conventional or also molecular imaging – about one third of patients had molecular imaging at the beginning – and we randomised them to best systemic treatment, which means endocrine deprivation therapy, enzalutamide etc., with or without radical prostatectomy as local treatment alternative. We randomised 132 patients and the study was preliminary closed due to the fact that the STAMPEDE arm H trial was published which showed a significant improvement of survival in patients with radiotherapy to the local tumour. However, we believe in this moment that it’s not ethical any more to offer no local treatment because this showed, of course, efficacy in this cohort.
So we randomised 132 patients, we followed them all up for five years and we evaluated as the primary outcome the cancer-specific mortality. Our results, the primary endpoint which was cancer-specific mortality, was reached. We have a significant improvement in cancer-specific mortality after five years for patients who received radical prostatectomy additionally to the systemic treatment. Of note, one has to say that in the best systemic treatment arm more patients initially got more aggressive systemic treatment like more chemotherapy, more next generation androgen receptor inhibitors. Despite that fact, even then we saw a nearly 10% reduction of cancer-specific mortality after five years.
What could be the implications of these results?
What we can say now is that radiotherapy and radical prostatectomy both should be performed in patients with limited metastatic spread at diagnosis. Both treatment modalities have their pros and cons but both have consistently shown improved cancer-specific survival advantages so patients benefit from this. However, we have to be aware that the complications after this kind of surgery are higher than in normal radical prostatectomy patients, which makes total sense – they are at more advanced stages – but this has to be counselled before we opt for surgery in patients.
