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ASCO 2021 | Abiraterone in metastatic castration-sensitive prostate cancer

Karim Fizazi, MD, PhD, Institut Gustave Roussy, Villejuif, France, describes the Phase III PEACE-1 trial (NCT01957436) of abiraterone and/or local radiotherapy in men with metastatic castration-sensitive prostate cancer (mCSPC). The trial intends to elucidate the efficacy of abiraterone combined with androgen deprivation therapy (ADT) and docetaxel, the current standard of care (SOC). In the 2×2 design trial, patients received either SOC alone or SOC with abiraterone and/or local radiotherapy. This interview took place at the American Society of Clinical Oncology (ASCO) 2021 Virtual Meeting.

Transcript (edited for clarity)

That is a phase three trial, testing new treatments on top of standard of care for men with de novo metastatic prostate cancer. And it’s sort of a general philosophy of the trial. It, as you probably know, we’ve seen great data in the last five years or so about new treatments in these men with M1 disease, with a demonstration that docetaxel improves overall survival. And then back in 2017, same for next-generation hormonal therapies, and also local radiation therapy, improves overall survival for these men, when they have oligometastatic disease...

That is a phase three trial, testing new treatments on top of standard of care for men with de novo metastatic prostate cancer. And it’s sort of a general philosophy of the trial. It, as you probably know, we’ve seen great data in the last five years or so about new treatments in these men with M1 disease, with a demonstration that docetaxel improves overall survival. And then back in 2017, same for next-generation hormonal therapies, and also local radiation therapy, improves overall survival for these men, when they have oligometastatic disease. What we don’t know at the moment is how best to combine this new treatment, together with androgen deprivation therapy in these men with M1 disease. And this is exactly what this one is asking.

So the design of this one is a two by two design. All men received standard of care, and for most of men enrolled in the trial, a standard of care consistent in androgen deprivation therapy, plus docetaxel. And then men are randomized to receive either standard of care alone – this is the control arm obviously – or standard of care, plus abiraterone; standard of care, plus local radiation therapy; and standard of care, plus abiraterone, plus radiation therapy.

Here at ASCO 2021, we are reporting the very first data of a trial, actually diet of abiraterone tested on top of standard of care, and mostly when standard of care consist of ADT plus docetaxel. So to make it easy, we just want to know whether three drugs; ADT, docetaxel plus abiraterone, is better than two drugs ADT plus docetaxel.

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