Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer : TALAPRO-2 phase III study design
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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
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| Enthalten in: |
Future oncology (London, England) - 18(2022), 4 vom: 13. Feb., Seite 425-436 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Agarwal, Neeraj [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 18.03.2022 Date Revised 28.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03395197 Citation Status MEDLINE |
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| doi: |
10.2217/fon-2021-0811 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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