So when we talk about this Optimus clinical trial, it’s built on a rationale that right now we treat all metastatic hormone-sensitive prostate cancers the same way. And the way is we give them an intensified treatment regimen consisting of either androgen deprivation therapy with androgen receptor pathway inhibitors or a triplet regimen of ADT, ARPI, and docetaxel...
So when we talk about this Optimus clinical trial, it’s built on a rationale that right now we treat all metastatic hormone-sensitive prostate cancers the same way. And the way is we give them an intensified treatment regimen consisting of either androgen deprivation therapy with androgen receptor pathway inhibitors or a triplet regimen of ADT, ARPI, and docetaxel. And when we treat the patients like this, more than 50% of the patients achieve a PSA response of 0.2 nanograms per ml or less, which we can call an optimal PSA response. And when we look at different clinical trials, like Enzalutamide, Titan, Latitude, Stampede, Erisense, and even real-world data sets, or the triplet trials of PEACE, we always find that a majority of these patients achieve this PSA response, and they have a very prolonged overall survival, which goes beyond seven years. However, when we keep on treating them with continuous androgen deprivation therapy, they get fatigue, gynecomastia, sexual function deterioration, adverse cardiovascular and bone health, as well as they get hot flashes, they have some cognitive decline and all these complications. So it’s possible that these patients who have achieved this optimal PSA response may be a candidate for de-escalation therapy, meaning they may get intermittent therapy without compromising their outcomes. So this Optimus clinical trial is a randomized trial. Patients are enrolled and they are treated with Relugolix with an androgen receptor pathway inhibitor and after six to twelve months if they achieve a PSA response of 0.2 they are randomized either to continue the current treatment or to stop both Relugolix and ARPI and get a treatment break and the treatment is then restarted if the PSA starts to rise or as per physician and patient discretion it’s a very pragmatic study design and then the primary endpoint is to look at the fatigue as per Brief Fatigue Inventory score at six months we for this study we have chosen Relugolix over Leuprolide because with Leuprolide if you give for like a year and a half the testosterone recovery may take years. However, and it may also depend on old patients. If they are older, testosterone recovery may take even more time. However, the Relugolix, as seen in the Phase III HERO trial, as well as real-world data published by me and my colleagues from Huntsman Cancer Institute, the testosterone recovery may be up to six weeks which is the median time and that’s why it’s an ideal treatment for de-escalation therapy which may allow testosterone recovery as well as hopefully a better quality of life.
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