Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 Phase III study design
Future oncology (London, England)(2022)
摘要
PARP inhibitors in combination with androgen receptor-targeted therapy have demonstrated potential in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Here, we describe the design and rationale of the multinational, Phase III, two-part TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide as a first-line treatment for patients with mCRPC with or without DNA damage response (DDR) alterations. This study has two co-primary end points: radiographic progression-free survival (rPFS) by blinded independent clinical review in all-corners (Cohort 1) and in patients with DDR alterations (Cohort 2). TALAPRO-2 will demonstrate whether talazoparib plus enzalutamide can significantly improve the efficacy of enzalutamide in terms of rPFS in both molecularly unselected and DDR-deficient patients with mCRPC (NCT03395197).
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关键词
androgen receptor,DDR,enzalutamide,mCRPC,PARP inhibitor,talazoparib
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