For most malignancies – colon, breast, lung cancer – for a long time we’ve been able to give patients systemic therapy prior to local control via either surgery or radiation therapy. And that has been shown to improve life expectancy in our patients. That hasn’t really been found in prostate cancer, in a large part because we didn’t actually have any drugs that worked. That whole landscape changed about 20 years ago with the introduction of a drug called docetaxel which is a very strong chemotherapy. Since that point in time, myself, Dr Taplin and others have been working in order to prove that if we gave that around the time of surgery it would actually improve patients’ outcomes, and that’s what this study actually has shown.

Could you outline the methodology?

The methodology was just a randomised placebo-controlled trial where half the patients got apalutamide and LHRH, which is a form of hormone ablation, and the other group got just LHRH plus a placebo. Patients were treated for six months then they all underwent surgery and then they were treated for an additional six months and then they were followed. The endpoints, there were two primary endpoints - the first was whether there was minimal residual disease in the prostate, so there was some effect on the local cancer, and the second was whether or not the patient developed metastatic disease in follow-up.

One of the key things is the inclusion criteria. These were patients that had high-risk prostate cancer, patients had Gleason 8, 9, 10 prostate cancer – very aggressive disease, the kind of patients which we don’t cure with surgery alone. This study was limited to that group of patients, not giving it to patients with less aggressive forms of the disease.

What did you find?

The findings of the study were from when we looked at what actually happened in the prostate there was a ninefold increase in minimal residual disease rate or complete response rate. So minimal residual disease was less than 5cc of cancer and complete response was obviously there was no cancer left in the sample, and that was around 9-10% in the patients that were treated with both agents and it was around 1% in the patients that had the placebo.

For the metastatic disease we saw a 20% reduction at five years in the risk of developing metastatic disease if you got the stronger treatment than if you got the weaker treatment.

What impact could these findings have in the clinic?

I think it’s going to have a tremendous impact in the clinic in two different ways. The first is the patient that presents to you that has very aggressive localised prostate cancer, we all know that they are very high risk for developing metastatic disease and dying, even if we treat them aggressively. By having the ability to give them an additional therapy that will help control the cancer and increase our ability to cure them, is a huge, huge step forward for the average urologist and medical oncologist that’s seeing the patient in the clinic.

The second important aspect of the study is this is the first study in prostate cancer that’s actually been able to demonstrate a benefit, an increase in our ability to manage this disease so patients actually are less likely to develop metastatic disease. So we finally have a bar that we can build off of. What I would expect is other companies and other treatments are going to find their way into this space which will actually have a tremendous impact over the next 5-10 years as we have more treatments available for our patients that have high-risk localise