GU Cancers 2018 | FALCON: radiopharmaceuticals for the management of recurrent prostate cancer

The FALCON trial is a multicenter UK study which set about to assess the clinical impact of using a special type of scan, called Fluciclovine PET/CT, in directing the management of patients with biochemical recurrence of prostate cancer. The primary aim was to assess the clinical impact. The primary endpoint set to address that aim was focused on the change in management of this patient population after having had the scan.

We recruited patients with their first presentation of biochemical recurrence of prostate cancer; these were patients who were being considered for salvage curative therapy. When these patients were registered on the trial, their clinicians proposed an intended treatment plan. The patients would then have the Fluciclovine scan, and with the scan report to hand, the clinicians would then revise the management plan if appropriate. When there was a change in the management plan, that would then count towards the primary endpoint. Essentially the primary endpoint is a percentage of patients with a change in management. The results that I’m going to present at the conference today are based on a pre-planned interim analysis.

In the study we had initially intended to recruit 180 patients and we stipulated in the protocol that the first 85 available patients will do an interim analysis of the primary endpoint. We stipulated that if more than 45 out of the 85 patients had management changes, then we would stop the trial for effectiveness. On the on flip side of the coin, we also stipulated that if 8 or less patients had management changes, then we would stop the trial for futility. The key finding that I’m presenting today is that 52 out of 85 patients (61%) had their management changed following Fluciclovine scanning which far exceeded the criteria we built for stopping the trial early. The first thing to say is that in this patient subset there was a very low median PSA and if you just turn back time on UK imaging practice to just under five years ago, at that time we rarely did scans with a PSA of less than one. So moving forward with these results we’ve shown that even in a predominantly low PSA population, we’re able to provide spatial information which helps to direct clinical management in almost two out of three patients. It should be something that’s worth doing in this population and hopefully it will help to improve patient outcomes which is the next thing that needs to be addressed of course, because changing management is one thing, but changing management to provide a fruitful outcome is another.