| Title: |
Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design |
| Authors: |
Agarwal, N; Azad, A; Shore, ND; Carles, J; Fay, AP; Dunshee, C; Karsh, LI; Paccagnella, ML; Santo, ND; Elmeliegy, M; Lin, X; Czibere, A; Fizazi, K |
| Publisher Information: |
TAYLOR & FRANCIS LTD |
| Publication Year: |
2022 |
| Collection: |
The University of Melbourne: Digital Repository |
| Description: |
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-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). Clinical Trial Registration: NCT03395197 (ClinicalTrials.gov). |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
1479-6694 |
| Relation: |
https://hdl.handle.net/11343/310225 |
| Availability: |
https://hdl.handle.net/11343/310225 |
| Rights: |
https://creativecommons.org/licenses/by-nc-nd/4.0 ; CC BY-NC-ND |
| Accession Number: |
edsbas.D984BF3F |
| Database: |
BASE |