---
title: "Talazoparib plus enzalutamide in high-volume mHNPC: randomized phase 2 results"
id: "nature-1-talazoparib-plus-enzalutamide-in-high-volume-metastatic-hormone-naive-prostate"
canonical_url: "https://medichelpline.com/clinical-feed/nature-1-talazoparib-plus-enzalutamide-in-high-volume-metastatic-hormone-naive-prostate"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04671-5"
published_at: "2026-10-14T10:47:20.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Talazoparib plus enzalutamide in high-volume mHNPC: randomized phase 2 results
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-1-talazoparib-plus-enzalutamide-in-high-volume-metastatic-hormone-naive-prostate
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04671-5)
- **Published At:** 2026-10-14T10:47:20.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- Investigators conducted a randomized phase 2 trial comparing **talazoparib** plus **enzalutamide** versus **enzalutamide** alone in men with high-volume metastatic hormone‑naive prostate cancer (**mHNPC**). - All 54 enrolled patients started androgen deprivation therapy and received a two-cycle enzalutamide lead-in before randomization. - Randomization was 1:2: 17 patients to enzalutamide alone and 37 patients to the combination; the source reported these arm sizes explicitly. - The primary endpoint was the proportion of patients with **PSA** <0.2 ng ml−1 at 12 months. - The combination arm met the prespecified efficacy threshold: 73% achieved PSA <0.2 at 12 months (95% CI 56–86%), with a reported P < 0.001 versus the threshold defined by the study team. - The control (enzalutamide) arm had a 12‑month PSA <0.2 rate of 64.7% (95% CI 38–86%); the reported exploratory comparison between arms yielded P = 0.54. - Safety differed: grade ≥3 adverse events occurred in 68% of patients on the combination versus 35% on enzalutamide alone; anemia was the predominant high‑grade toxicity (41% in combination arm). - Two fatal therapy‑emergent myeloid neoplasms occurred in the combination arm; the authors reported underlying genomic susceptibility in those patients. - Paired tumor biopsies (baseline and after enzalutamide lead‑in) showed marked transcriptional reprogramming with suppression of proliferation‑associated and **HRR**-related gene expression, but no functional impairment of homologous recombination activity was observed according to the report. - Overall, the study team concluded that while the combination demonstrated clinical activity in high-volume mHNPC, it did not show clear additional clinical benefit over enzalutamide alone in this biomarker‑unselected population and was associated with increased toxicity. - The article cites ClinicalTrials.gov identifier NCT04332744.
## Clinical Analysis & Structured Key Points
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[articles](https://www.nature.com/nm/articles?type=article) 4. article Talazoparib plus enzalutamide in high-volume metastatic hormone-naive prostate cancer: a randomized phase 2 trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04671-5.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04671-5.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 14 October 2026 # Talazoparib plus enzalutamide in high-volume metastatic hormone-naive prostate cancer: a randomized phase 2 trial * [Francesca Zacchi](https://www.nature.com/articles/s41591-026-04671-5#auth-Francesca-Zacchi-Aff1-Aff2) [ORCID: orcid.org/0000-0002-7448-7822](https://orcid.org/0000-0002-7448-7822)[1](https://www.nature.com/articles/s41591-026-04671-5#Aff1),[2](https://www.nature.com/articles/s41591-026-04671-5#Aff2), * [Elena Castro](https://www.nature.com/articles/s41591-026-04671-5#auth-Elena-Castro-Aff3)[3](https://www.nature.com/articles/s41591-026-04671-5#Aff3), * [Kathleen Imbach](https://www.nature.com/articles/s41591-026-04671-5#auth-Kathleen-Imbach-Aff1-Aff4)[1](https://www.nature.com/articles/s41591-026-04671-5#Aff1),[4](https://www.nature.com/articles/s41591-026-04671-5#Aff4), * [Alejo Rodriguez-Vida](https://www.nature.com/articles/s41591-026-04671-5#auth-Alejo-Rodriguez_Vida-Aff5)[5](https://www.nature.com/articles/s41591-026-04671-5#Aff5), * [Sara Simonetti](https://www.nature.com/articles/s41591-026-04671-5#auth-Sara-Simonetti-Aff1)[1](https://www.nature.com/articles/s41591-026-04671-5#Aff1), * [Begoña Mellado](https://www.nature.com/articles/s41591-026-04671-5#auth-Bego_a-Mellado-Aff6)[6](https://www.nature.com/articles/s41591-026-04671-5#Aff6), * [Gisela Mir Arnau](https://www.nature.com/articles/s41591-026-04671-5#auth-Gisela-Mir_Arnau-Aff1) [ORCID: orcid.org/0009-0007-1180-5604](https://orcid.org/0009-0007-1180-5604)[1](https://www.nature.com/articles/s41591-026-04671-5#Aff1), * [Daniel Aguilar](https://www.nature.com/articles/s41591-026-04671-5#auth-Daniel-Aguilar-Aff1)[1](https://www.nature.com/articles/s41591-026-04671-5#Aff1), * [Daniel Castellano](https://www.nature.com/articles/s41591-026-04671-5#auth-Daniel-Castellano-Aff3) [ORCID: orcid.org/0000-0002-9106-0687](https://orcid.org/0000-0002-9106-0687)[3](https://www.nature.com/articles/s41591-026-04671-5#Aff3), * [Miguel Angel Climent](https://www.nature.com/articles/s41591-026-04671-5#auth-Miguel_Angel-Climent-Aff7)[7](https://www.nature.com/articles/s41591-026-04671-5#Aff7), * [Manuel J. 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Zurita](https://www.nature.com/articles/s41591-026-04671-5#auth-Amado_J_-Zurita-Aff12) [ORCID: orcid.org/0000-0002-3805-7307](https://orcid.org/0000-0002-3805-7307)[12](https://www.nature.com/articles/s41591-026-04671-5#Aff12) & * … * [Joaquin Mateo](https://www.nature.com/articles/s41591-026-04671-5#auth-Joaquin-Mateo-Aff1-Aff13) [ORCID: orcid.org/0000-0001-5336-2548](https://orcid.org/0000-0001-5336-2548)[1](https://www.nature.com/articles/s41591-026-04671-5#Aff1),[13](https://www.nature.com/articles/s41591-026-04671-5#Aff13) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04671-5#citeas) Save article [ View saved research ](https://www.nature.com/saved-research) ## Abstract Combining inhibition of poly(ADP-ribose) polymerase and androgen receptor (AR) pathway has demonstrated clinical activity in men with metastatic prostate cancer, although the extent of benefit in tumors lacking homologous recombination repair (_HRR_) gene alterations remains uncertain. We conducted a randomized phase 2 trial evaluating talazoparib plus enzalutamide versus enzalutamide alone in men with high-volume metastatic hormone-naive prostate cancer (mHNPC). Fifty-four patients starting androgen deprivation therapy received two cycles of enzalutamide lead-in before 1:2 randomization to enzalutamide (_n_ = 17) or enzalutamide plus talazoparib (_n_ = 37). The primary endpoint was met, with a 73% prostate-specific antigen (PSA) <0.2 ng ml−1 response rate at 12 months in the combination arm (95% confidence interval (CI) = 56–86%), exceeding the prespecified efficacy threshold (_P_ < 0.001); the PSA <0.2 rate in the control arm was 64.7% (95% CI = 38–86%, _P_ = 0.54 for exploratory comparison between arms). Grade ≥3 adverse events occurred in 68% patients receiving the combination versus 35% with enzalutamide alone, predominantly anemia (41%). Two fatal therapy-emergent myeloid neoplasms occurred in the enzalutamide plus talazoparib arm in patients with underlying genomic susceptibility. Analyses of paired tumor biopsies acquired at baseline and during enzalutamide lead-in phase demonstrated marked tumor transcriptional reprogramming after AR inhibition, including suppression of proliferation-associated and HRR-related gene expression programs, but without functional impairment of homologous recombination activity. Overall, talazoparib plus enzalutamide demonstrated clinical activity in patients with high-volume mHNPC but did not establish clear additional clinical benefit over enzalutamide alone in this biomarker-unselected population, while being associated with increased toxicity. ClinicalTrials.gov identifier: [NCT04332744](https://clinicaltrials.gov/study/NCT04332744). ### Explore related subjects Discover the latest articles and news in related subjects. * [Drug development](https://www.nature.com/subjects/drug-development) * [Translational research](https://www.nature.com/subjects/translational-research) ## Main Prostate cancer (PCa) is the second most frequent cancer and a common leading cause of cancer death among men[1](https://www.nature.com/articles/s41591-026-04671-5#ref-CR1 "Bray, F. et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 74, 229–263 \(2024\)."). In the metastatic hormone-naive prostate cancer (mHNPC) setting, multiple phase 3 trials have reshaped the therapeutic landscape, demonstrating that intensifying androgen deprivation therapy (ADT) combined with androgen receptor pathway inhibitors (ARPIs) significantly improves overall survival (OS) and delays progression to metastatic castration-resistant prostate cancer (mCRPC)[2](https://www.nature.com/articles/s41591-026-04671-5#ref-CR2 "Armstrong, A. J. et al. ARCHES: a randomized, phase III study of androgen deprivation therapy with enzalutamide or placebo in men with metastatic hormone-sensitive prostate cancer. J. Clin. Oncol. 37, 2974–2986 \(2019\)."),[3](https://www.nature.com/articles/s41591-026-04671-5#ref-CR3 "Chi, K. N. et al. Apalutamide in patients with metastatic castration-sensitive prostate cancer: final survival analysis of the randomized, double-blind, phase III TITAN study. J. Clin. Oncol. 39, 2294–2303 \(2021\)."),[4](https://www.nature.com/articles/s41591-026-04671-5#ref-CR4 "James, N. D. et al. Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5-year follow-up results from the STAMPEDE randomised trial \(NCT00268476\). Int. J. Cancer 151, 422–434 \(2022\)."),[5](https://www.nature.com/articles/s41591-026-04671-5#ref-CR5 "Saad, F. et al. Darolutamide in combination with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase III ARANOTE trial. J. Clin. Oncol. 42, 4271–4281 \(2024\)."),[6](https://www.nature.com/articles/s41591-026-04671-5#ref-CR6 "Fizazi, K. et al. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer \(LATITUDE\): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 20, 686–700 \(2019\)."). Additional strategies, including docetaxel chemotherapy[7](https://www.nature.com/articles/s41591-026-04671-5#ref-CR7 "Sweeney, C. J. et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N. Engl. J. Med. 373, 737–746 \(2015\)."),[8](https://www.nature.com/articles/s41591-026-04671-5#ref-CR8 "Clarke, N. W. et al. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. Ann. Oncol. 30, 1992–2003 \(2019\)."), radiotherapy to the primary tumor[9](https://www.nature.com/articles/s41591-026-04671-5#ref-CR9 "Parker, C. C. et al. Radiotherapy to the primary tumour for newly diagnosed, metastatic prostate cancer \(STAMPEDE\): a randomised controlled phase 3 trial. Lancet 392, 2353–2366 \(2018\).") and triplet regimens combining ADT, docetaxel and ARPI, have further improved outcomes in selected patient populations[10](https://www.nature.com/articles/s41591-026-04671-5#ref-CR10 "Fizazi, K. et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer \(PEACE-1\): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet 399, 1695–1707 \(2022\)."),[11](https://www.nature.com/articles/s41591-026-04671-5#ref-CR11 "Smith, M. R. et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer. N. Engl. J. Med. 386, 1132–1142 \(2022\)."). Among patients with metastatic disease, those with high-volume mHNPC have the poorest prognosis despite treatment intensification[12](https://www.nature.com/articles/s41591-026-04671-5#ref-CR12 "Antonarakis, E. S. et al. Carboplatin, cabazitaxel, and abiraterone in high-volume metastatic castration-sensitive prostate cancer: the CASCARA phase II study. Clin. Cancer Res. 32, 2403–2412 \(2026\)."), highlighting a persistent unmet need for more effective upfront therapeutic strategies. Despite these therapeutic advances, clinical outcomes remain heteroge
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> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.