Optimizing treatment for metastatic castration-resistant prostate cancer: Food and Drug Administration-approved therapies, emerging strategies, and biomarker-driven approaches

Cancer. 2025 Aug 15;131(16):e70037. doi: 10.1002/cncr.70037.

Abstract

Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal stage of disease progression despite substantial therapeutic advancements. Driven largely by androgen receptor (AR) signaling, prostate cancer eventually develops resistance to AR-directed therapies, necessitating alternative strategies. In recent years, several novel agents have received US Food and Drug Administration approval for mCRPC, including next-generation AR-signaling inhibitors, poly(adenosine diphosphate-ribose) polymerase inhibitors, targeted radioligand therapy, and immunotherapy. Although these treatments have extended survival, resistance mechanisms and optimal sequencing remain key challenges. Molecular profiling has uncovered distinct genomic alterations-such as defects in homologous recombination repair genes and mismatch repair alterations-that guide therapeutic decision making. In parallel, novel treatment modalities are being explored, including AR degraders, antibody-drug conjugates, T-cell engagers, and epigenetic modulators. This review critically evaluates current US Food and Drug Administration-approved therapies for mCRPC, examines emerging therapeutic strategies under clinical development, and discusses evolving biomarker-driven approaches that aim to personalize treatment and improve outcomes.

Keywords: androgen receptor‐signaling inhibitors (ARSIs); metastatic castration‐resistant prostate cancer (mCRPC); poly(adenosine diphosphate‐ribose) polymerase (PARP) inhibitors; precision oncology; prostate cancer; radioligand therapy; targeted therapy.

Publication types

  • Review

MeSH terms

  • Androgen Receptor Antagonists / therapeutic use
  • Biomarkers, Tumor* / genetics
  • Biomarkers, Tumor* / metabolism
  • Drug Approval
  • Drug Resistance, Neoplasm
  • Humans
  • Immunotherapy / methods
  • Male
  • Molecular Targeted Therapy
  • Neoplasm Metastasis
  • Poly(ADP-ribose) Polymerase Inhibitors / therapeutic use
  • Prostatic Neoplasms, Castration-Resistant* / drug therapy
  • Prostatic Neoplasms, Castration-Resistant* / genetics
  • Prostatic Neoplasms, Castration-Resistant* / pathology
  • Prostatic Neoplasms, Castration-Resistant* / therapy
  • Receptors, Androgen / genetics
  • Receptors, Androgen / metabolism
  • United States
  • United States Food and Drug Administration

Substances

  • Biomarkers, Tumor
  • Receptors, Androgen
  • Poly(ADP-ribose) Polymerase Inhibitors
  • Androgen Receptor Antagonists