Today the topic is to speak about non-metastatic CRPC and what is new in this indication so far. Three drugs in the metastatic setting, a three-year phase III trial looking at apalutamide, enzalutamide or darolutamide compared to placebo and the primary endpoint was metastatic free survival. We have outstanding data regarding these three new hormonal treatments.
In daily practice when you see a patient in consultation these patients usually have had a local treatment, either a prostatectomy or radiation therapy and at relapse, at PSA relapse, they receive ADT. Then at one stage they have hormone resistant but not yet metastatic so we call that non-metastatic CRPC. So about these three drugs we have almost the same hazard ratio in terms of efficacy ranging from 0.28-0.41. In terms of toxicity the toxicity is quite different between these three drugs. I would say that darolutamide is maybe the safer drug but the patients were seen every four months to report side effects whereas in the apalutamide study patients had to come every month to say whether or not they were in a good shape and report side effects. So it’s difficult to compare two studies where you know the visits are not done at the same time, with the same frequency I would say.
So, nevertheless, today it’s a good opportunity for the patients to have these kinds of drugs but it depends on how you handle the patients in terms of imaging. Usually we perform bone scan and CT scan and we can say that those patients have no metastatic disease but they are in a CRPC situation. But now more and more countries use PSMA CaP scan allowing to find much more metastasis than the normal imaging which is bone scan and CT scan.
So in France, for instance, we don’t have access to PSMA imaging so we may have around 1,500 patients non-metastatic CRPC that we can treat with this drug. But if you perform the most interesting imaging, PSMA, you will have a lower number of patients that you can refer to this similar treatment.