Nubeqa (darolutamide)

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

P1/2, N=203, Recruiting, Novartis Pharmaceuticals | Not yet recruiting --> Recruiting

P1, N=60, Not yet recruiting, Daiichi Sankyo

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

P3, N=977, Active, not recruiting, Bayer | Recruiting --> Active, not recruiting

Key developments include next-generation AR pathway inhibitors, such as darolutamide, with improved safety profiles; PARP inhibitors for patients with DNA repair gene mutations; and PSMA-targeted radioligand therapy. The therapeutic landscape is also expanding to include novel targets such as the heat shock response, with HSF1 inhibitors like NXP800 in clinical trials for treatment-refractory disease. By targeting this molecular heterogeneity, ongoing research aims to deliver more effective, personalized treatments to improve survival and quality of life for men with advanced prostate cancer.

P2, N=21, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

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.

P=N/A, N=184, Not yet recruiting, Peking University First Hospital; Peking University First Hospital

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=51, Recruiting, Vandana Abramson | Not yet recruiting --> Recruiting

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.