Darolutamide Added to Docetaxel Augments Antitumor Effect in Models of Prostate Cancer through Cell Cycle Arrest at the G1-S Transition

Mol Cancer Ther. 2024 May 2;23(5):711-720. doi: 10.1158/1535-7163.MCT-23-0420.

Abstract

Resistance to taxane chemotherapy is frequently observed in metastatic prostate cancer. The androgen receptor (AR) is a major driver of prostate cancer and a key regulator of the G1-S cell-cycle checkpoint, promoting cancer cell proliferation by irreversible passage to the S-phase. We hypothesized that AR signaling inhibitor (ARSi) darolutamide in combination with docetaxel could augment antitumor effect by impeding the proliferation of taxane-resistant cancer cells. We monitored cell viability in organoids, tumor volume, and PSA secretion in patient-derived xenografts (PDX) and analyzed cell cycle and signaling pathway alterations. Combination treatment increased antitumor effect in androgen-sensitive, AR-positive prostate cancer organoids and PDXs. Equally beneficial effects of darolutamide added to docetaxel were observed in a castration-resistant model, progressive on docetaxel, enzalutamide, and cabazitaxel. In vitro studies showed that docetaxel treatment with simultaneous darolutamide resulted in a reduction of cells entering the S-phase in contrast to only docetaxel. Molecular analysis in the prostate cancer cell line LNCaP revealed an upregulation of cyclin-dependent kinase inhibitor p21, supporting blockade of S-phase entry and cell proliferation. Our results provide a preclinical support for combining taxanes and darolutamide as a multimodal treatment strategy in patients with metastatic prostate cancer progressive on ARSi and taxane chemotherapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antineoplastic Combined Chemotherapy Protocols / pharmacology
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Cell Cycle Checkpoints / drug effects
  • Cell Line, Tumor
  • Cell Proliferation / drug effects
  • Docetaxel* / pharmacology
  • Drug Synergism
  • Humans
  • Male
  • Mice
  • Prostatic Neoplasms* / drug therapy
  • Prostatic Neoplasms* / pathology
  • Pyrazoles / pharmacology
  • Receptors, Androgen / metabolism
  • Xenograft Model Antitumor Assays*

Substances

  • Docetaxel
  • darolutamide
  • Pyrazoles
  • Receptors, Androgen

Grants and funding