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Neoadjuvant darolutamide plus androgen deprivation therapy for high-risk and locally advanced prostate cancer: a multicenter, open-label, single-arm, phase II trial.
World J Urol
January 2025
Department of Urology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.
Propose: This study aimed to evaluate the efficacy and safety of neoadjuvant treatment of darolutamide, a next-generation androgen receptor inhibitor, plus androgen deprivation therapy (ADT) for patients with locally advanced prostate cancer (LAPC).
Methods: This single-arm, multicenter, open-label phase II trial (ClinicalTrials.gov: NCT05249712, 2022-01-01), recruited 30 localized high-risk/very high-risk prostate cancer (HRPCa/VHRPCa) patients from three centers in China between 2021 and 2023.
Triplet or Doublet Therapy in Metastatic Hormone-sensitive Prostate Cancer Patients: An Updated Network Meta-analysis Including ARANOTE Data.
Eur Urol Focus
December 2024
Department of Urology, University Hospital Frankfurt, Goethe University Frankfurt am Main, Frankfurt am Main, Germany; Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address:
The treatment landscape for metastatic hormone-sensitive prostate cancer (mHSPC) has been extended by another phase 3 randomized control trial (ARANOTE) demonstrating favorable outcomes of a doublet therapy combining the androgen receptor pathway inhibitor (ARPI) darolutamide with androgen deprivation therapy (ADT) over ADT monotherapy. Owing to differences in trial designs, patient enrollment, and most notably different control treatment regimens, we hereby present an updated network meta-analysis (NMA) embedding the doublet therapy with darolutamide within the current treatment regimens. In NMA-derived ranking, darolutamide and ADT showed similar oncological efficacy to the already known doublet therapies for progression-free survival (p = 0.
View Article and Find Full Text PDFCentral Nervous System Toxicity in Prostate Cancer Patients Treated with Androgen Receptor Signaling Inhibitors: A Systematic Review, Meta-analysis, and Network Meta-analysis.
Clin Genitourin Cancer
October 2024
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan; Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Urology, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, Research Center for Evidence Medicine, Tabriz University of Medical Science, Tabriz, Iran. Electronic address:
Background: Androgen-receptor signaling inhibitors (ARSIs) significantly improve survival in systemic therapy for advanced/metastatic prostate cancer (PCa) patients; however possible central nervous system (CNS) toxicity is an unaddressed concern. We aimed to assess and compare the incidence of CNS-related adverse events (AEs) secondary to the treatment of PCa patients with different ARSIs.
Materials: In August 2023, a comprehensive seach was conducted in three databases for randomized controlled trials (RCTs) of PCa patients receiving ARSIs plus ADT.
Sequential versus concomitant treatment of androgen receptor signaling inhibitors and docetaxel for metastatic hormone-sensitive prostate cancer: an network meta-analysis.
Front Pharmacol
October 2024
Department of Urology, Peking University Shougang Hospital, Beijing, China.
Background: Androgen receptor signaling inhibitors (ARSis), when administered sequentially or in combination with docetaxel and androgen deprivation therapy (ADT), have been shown to enhance overall survival (OS) and progression-free survival (PFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nonetheless, the optimal sequence for administering chemotherapy and ARSis remains to be determined.
Objective: To compare the efficacy of ARSis sequential therapy with ARSis combined therapy for mHSPC, and to evaluate the efficacy and safety of different combination regimens.
Darolutamide in Japanese patients with metastatic hormone-sensitive prostate cancer: Phase 3 ARASENS subgroup analysis.
Cancer Med
November 2024
Department of Urology, Toho University Sakura Medical Center, Sakura, Japan.
Article Synopsis
- Darolutamide combined with androgen-deprivation therapy (ADT) and docetaxel significantly lowered the risk of death by 32.5% in the ARASENS study, indicating its effectiveness for treating metastatic hormone-sensitive prostate cancer (mHSPC).
- In the Japanese subgroup analysis of 148 patients, higher percentages of participants were older (≥75 years) and had lower body mass indexes compared to the overall study population, but the treatment showed a similar safety and efficacy profile.
- While overall survival trends were positive for darolutamide in Japanese patients, the combined treatment was well tolerated, with no new safety concerns identified, despite some patients experiencing more frequent adverse events like neutropenia.
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