Important considerations about patient populations in mCRPC trials
Neeraj Agarwal (Huntsman Cancer Institute, University of Utah, USA) identifies an important caveat for patient populations in phase 3 first-line mCRPC trials, which he considers “the single most debated point” at conferences. View transcript.
Neeraj Agarwal, FASCO, MD
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This is a broad question. There are so many trials which are going on in the first line mCRPC setting. But I think one of the most important caveat we have to keep in mind that many patients do not have disease progression on a novel hormonal therapy when they reach mCRPC space.
I think that is a single most debated point in all national meetings or forums where many of my esteemed colleagues say that we don't have that patient population exist in mCRPC space which has not progressed on a prior mCRPC hormonal therapy. And that is simply I respectfully disagree with that notion. We just saw real world studies and we presented that in multiple meetings and published them that even in metastatic hormone sensitive prostate cancer setting 40% patients have not seen any intensification of ADT.
Many patients have only progressed on chemotherapy with docetaxel and those 30 to 40% patients who have seen a novel hormonal therapy in the metastatic castration sensitive prostate cancer even they may not have had disease progression. All of them may not have disease progression on a novel hormonal therapy because many of them actually discontinue or take a break after years of therapy in the metastatic hormone sensitive prostate cancer setting. So we already have a substantial number of patients who are progressing to mCRPC without disease progression on NHT in hormone-sensitive metastatic setting. But then we also have many substantial number of patients who get surgery or radiation for their metachronous prostate cancer, meaning they're present with localized prostate cancer treated with radiation or surgery.
They have biochemical recurrence which is treated with intermittent or continuous androgen deprivation therapy. And a time comes when their PSA starts rising with castrate level of testosterone and they get a scan done whether a conventional scan or a PSMA PET scan and they are found to have metastatic disease. And none of these patients have really progressed or even exposed to a novel hormonal therapy before they reach the mCRPC state. So I think this is a single most important factor we have to consider when we are thinking about the patient population, which is included in the first line mCRPC trial. And there is a room for NST based combination therapies in this setting.
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