Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design
The latest clinical trial protocol, published in Future Oncology, discusses the phase III, TALAPRO-2 study that compares talazoparib plus enzalutamide versus placebo plus enzalutamide as a first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without DNA damage response (DDR) alterations.
Abstract
PARP inhibitors in combination with androgen receptor-targeted therapy have demonstrated potential in the treatment of 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 DDR alterations. This study has two co-primary end points: radiographic progression-free survival (rPFS) by blinded independent clinical review in all-comers (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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