apalutamide

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.

P2, N=324, Active, not recruiting, NRG Oncology | Trial primary completion date: Mar 2026 --> Mar 2025

Direct AR antagonists (apalutamide, bicalutamide) produced greater TMPRSS2 suppression than Gonadotropin-Releasing Hormone modulators or androgen biosynthesis inhibitors. Our findings demonstrate that ADT significantly reduces pulmonary TMPRSS2 expression, with direct AR antagonists showing the strongest effect. This suggests a potential mechanistic explanation for differential COVID-19 susceptibility and provides a rationale for investigating AR-targeted therapies as potential protective interventions against SARS-CoV-2 infection severity.

P3, N=1260, Recruiting, Alliance for Clinical Trials in Oncology | Not yet recruiting --> Recruiting | Initiation date: May 2025 --> Nov 2025

Our study provides important insight that we analyzed RWD and evaluated comparative drug safety across all type of prostate cancer. Although we could not make a conclusion whether which is the safest ARPI, we can suggest that each ARPIs have different types of AEs hence we can use this information during choosing ARPIs for prostate cancer patients.