apalutamide

We detail the evidence supporting the integration of systemic agents like abiraterone, enzalutamide, and darolutamide into both hormone-sensitive and castration-resistant settings. Furthermore, we highlight the expanding role of radioligand therapies, including radium-223 and Lutetium-177-labeled PSMA-617 (Lu-PSMA-617), as well as the growing impact of PARP inhibitors in genomically selected patients. The emergence of theranostic strategies and next-generation sequencing has paved the way for personalized treatment algorithms, moving toward a truly precision oncology model in PCa. This comprehensive review synthesizes current therapeutic strategies, clinical trial evidence, and future directions aimed at optimizing outcomes and quality of life for patients with advanced prostate cancer.

P=N/A, N=1300, Completed, Pfizer | Recruiting --> Completed

P1/2, N=174, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting

P2, N=25, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> Nov 2028 | Trial primary completion date: Jan 2027 --> Nov 2028

P=N/A, N=102, Recruiting, Ankara Etlik City Hospital | Not yet recruiting --> Recruiting

P3, N=504, Completed, Alliance Foundation Trials, LLC. | Active, not recruiting --> Completed | Trial completion date: Jan 2026 --> Jun 2025

This case report highlights the importance of recognizing and managing apalutamide-associated skin AEs. The development of these AEs appears to be dose-dependent, and early discontinuation or dose reduction of the drug is crucial for controlling the symptoms. A multidisciplinary approach involving oncologists and dermatologists is recommended to optimize the treatment strategy and maintain the patients' quality of life.

P3, N=2517, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Jul 2029 --> Oct 2028

P3, N=420, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2026 --> Oct 2028

Compared to apalutamide, the ICER for enzalutamide was ¥643,309/QALY, while for darolutamide, the ICER was -¥40,625/QALY. For Chinese mHSPC patients, darolutamide is the most cost-effective treatment at a WTP threshold of ¥287,391/QALY, followed by apalutamide, with enzalutamide being less favorable.

Dual inhibition of CDK4 and CDK6 and the androgen receptor pathway with abemaciclib plus abiraterone did not improve radiographic progression-free survival compared with abiraterone alone in the CYCLONE 2 study population with mCRPC. Safety of the combination was consistent with the previously reported safety of the individual drugs. Additional research is required to identify effective combination therapies for patients with mCRPC, especially in those presenting with adverse prognostic characteristics.