GU Cancers 2022 | PRESIDE: investigating continued treatment with enzalutamide in PC following disease progression
Axel S. Merseburger, MD, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany outlines the randomized, double-blind Phase III PRESIDE (NCT02288247) clinical trial investigating whether there is a benefit to continued treatment with enzalutamide when starting treatment with docetaxel and prednisolone in patients with metastatic castration-resistant prostate cancer (mCRPC) following disease progression on enzalutamide. Patients initially receive open-label treatment with enzalutamide until disease progression, thereafter patients are randomized to either continue enzalutamide with the addition of docetaxel or to docetaxel monotherapy. The primary endpoint was progression-free survival (PFS) and secondary endpoints include time to prostate-specific antigen (PSA) progression, PSA response and objective response rate (ORR). The primary endpoint was met, a statistically significant PFS benefit of a 28% advantage was achieved when continuing enzalutamide with docetaxel and prednisolone. This interview took place at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2022 in San Francisco, CA.
Transcript (edited for clarity)
On behalf of my co-authors and investigators, I was able to present the PRESIDE trial today in the plenary recession on prostate cancer. PRESIDE is a randomized Phase III B trial on men with metastatic castration resistant prostate cancer, receiving enzalutamide. And once it comes to progression, we are randomizing two arms, one arm combining with docetaxel and prednisone, and the other one, placebo was combined with docetaxel and prednisone...
On behalf of my co-authors and investigators, I was able to present the PRESIDE trial today in the plenary recession on prostate cancer. PRESIDE is a randomized Phase III B trial on men with metastatic castration resistant prostate cancer, receiving enzalutamide. And once it comes to progression, we are randomizing two arms, one arm combining with docetaxel and prednisone, and the other one, placebo was combined with docetaxel and prednisone. So the question and the main objective was what is the benefit of maintaining the therapy upon progression with enzalutamide? The primary endpoint was progression-free survival, and fortunately, the primary endpoint was positive, was met, statistically significant PFS benefit. Hazard ratio was a 28% advantage when continuation with enzalutamide in combination with docetaxel and prednisone.
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