TALAPRO-2

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Phase

Phase 3

Status

Active not recruiting

Conditions

mCRPC

Interventions

Talazoparib with enzalutamide; Placebo with enzalutamide

Arms

• Combination arm · Experimental
• Monotherapy arm · Active comparator

Enrollment

1,054

Primary outcomes

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
• Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
• Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
• Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
• Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
• Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
• Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
• BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2

Sponsor

Pfizer with Astellas Pharma Inc

Start

Dec 18, 2017

Primary completion

Oct 3, 2022

Results posted

Yes

Registry record

NCT03395197 · updated Sep 29, 2026

• Yajima S, Yoshida S, Chen W, Fukushima H, Tanaka H, Sato H, Hirakawa A, Masuda H, Fujii Y. Exploratory Time-Dependent Patterns in Estimated Treatment Effect of Talazoparib Plus Enzalutamide in HRR Non-Deficient or Unknown Metastatic Castration-Resistant Prostate Cancer: A Post Hoc Analysis of the TALAPRO-2 Trial. Int J Urol. 2026 Jul;33(7):e70582. doi: 10.1111/iju.70582. PubMed 42502892
• Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. A plain language summary of the final overall survival results from the TALAPRO-2 study comparing talazoparib plus enzalutamide with placebo plus enzalutamide for patients with advanced prostate cancer. Future Oncol. 2026 Jun;22(14):1687-1702. doi: 10.1080/14796694.2026.2668552. Epub 2026 Jun 9. PubMed 42261883
• Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Kalac M, Laird AD, Kennedy D, Agarwal N. A plain language summary of the final overall survival results from the TALAPRO-2 study comparing talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer and changes in specific DNA repair genes. Future Oncol. 2026 Jun;22(14):1669-1685. doi: 10.1080/14796694.2026.2661093. Epub 2026 Jun 4. PubMed 42237765
• Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Szczylik C, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Saad F, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Kalac M, Kennedy D, Fizazi K. Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):447-460. doi: 10.1016/S0140-6736(25)00684-1. Epub 2025 Jul 16. PubMed 40683290
• Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Kalac M, Douglas Laird A, Kennedy D, Agarwal N. Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet. 2025 Aug 2;406(10502):461-474. doi: 10.1016/S0140-6736(25)00683-X. Epub 2025 Jul 16. PubMed 40683287
• Fay AP, Fizazi K, Matsubara N, Azad AA, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Cislo P, Chang J, Healy CG, Niyazov A, Agarwal N. First-line talazoparib plus enzalutamide versus placebo plus enzalutamide in men with metastatic castration-resistant prostate cancer and homologous recombination repair gene alterations: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet Oncol. 2025 Apr;26(4):481-490. doi: 10.1016/S1470-2045(25)00031-2. PubMed 40179907
• Matsubara N, Azad AA, Agarwal N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Cislo P, Chang J, Healy CG, Niyazov A, Fizazi K. First-line talazoparib plus enzalutamide versus placebo plus enzalutamide for metastatic castration-resistant prostate cancer: patient-reported outcomes from the randomised, double-blind, placebo-controlled, phase 3 TALAPRO-2 trial. Lancet Oncol. 2025 Apr;26(4):470-480. doi: 10.1016/S1470-2045(25)00030-0. PubMed 40179906
• Matsubara N, Miyake H, Uemura H, Mizokami A, Kikukawa H, Kosaka T, Nishimura K, Nakamura M, Kobayashi K, Komaru A, Mori Y, Toyoizumi S, Hori N, Umeyama Y, Uemura H. Phase 3 Study of Talazoparib Plus Enzalutamide Versus Placebo Plus Enzalutamide as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer: TALAPRO-2 Japanese Subgroup Analysis. Cancer Med. 2025 Jan;14(1):e70333. doi: 10.1002/cam4.70333. PubMed 39737542
• Azad AA, Fizazi K, Matsubara N, Saad F, De Giorgi U, Joung JY, Fong PCC, Jones RJ, Zschabitz S, Oldenburg J, Shore ND, Dunshee C, Carles J, Fay AP, Lin X, DeAnnuntis L, Di Santo N, Zielinski MA, Agarwal N. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: Safety analyses from the randomized, placebo-controlled, phase III TALAPRO-2 study. Eur J Cancer. 2024 Dec;213:115078. doi: 10.1016/j.ejca.2024.115078. Epub 2024 Oct 20. PubMed 39486165
• Agarwal N, Saad F, Azad AA, Mateo J, Matsubara N, Shore ND, Chakrabarti J, Chen HC, Lanzalone S, Niyazov A, Fizazi K. The TALAPRO-3 study design: a plain language summary. Future Oncol. 2024;20(30):2225-2231. doi: 10.1080/14796694.2024.2363131. Epub 2024 Jul 24. PubMed 39451095
• Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Heinrich D, Szczylik C, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Di Santo N, Zohren F, Fizazi K. Plain language summary of the results from the TALAPRO-2 study: Talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer. Future Oncol. 2024;20(29):2123-2135. doi: 10.1080/14796694.2024.2362108. Epub 2024 Jul 12. PubMed 38995237
• Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7. PubMed 38452327
• Fizazi K, Azad AA, Matsubara N, Carles J, Fay AP, De Giorgi U, Joung JY, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Ye D, Lin X, Healy CG, Di Santo N, Laird AD, Zohren F, Agarwal N. First-line talazoparib with enzalutamide in HRR-deficient metastatic castration-resistant prostate cancer: the phase 3 TALAPRO-2 trial. Nat Med. 2024 Jan;30(1):257-264. doi: 10.1038/s41591-023-02704-x. Epub 2023 Dec 4. PubMed 38049622
• Agarwal N, Azad AA, Carles J, Fay AP, Matsubara N, Heinrich D, Szczylik C, De Giorgi U, Young Joung J, Fong PCC, Voog E, Jones RJ, Shore ND, Dunshee C, Zschabitz S, Oldenburg J, Lin X, Healy CG, Di Santo N, Zohren F, Fizazi K. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Jul 22;402(10398):291-303. doi: 10.1016/S0140-6736(23)01055-3. Epub 2023 Jun 4. PubMed 37285865
• 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. Talazoparib plus enzalutamide in metastatic castration-resistant prostate cancer: TALAPRO-2 phase III study design. Future Oncol. 2022 Feb;18(4):425-436. doi: 10.2217/fon-2021-0811. Epub 2022 Jan 26. PubMed 35080190