Darolutamide

Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025  = 4.12, IC 025  = 1.70, N  = 30; EudraVigilance, ROR 025  = 11.54, IC 025  = 2.84, N  = 55; JADER, ROR 025  = 2.90, IC 025  = 1.33, N  = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N  = 29, EudraVigilance, ROR 025  = 30.96, IC 025  = 3.74, N  = 58; JADER, ROR 025  = 5.34, IC 025  = 1.85, N  = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N  = 38; EudraVigilance, ROR 025  = 25.06, IC 025  = 3.53, N  = 55; JADER, ROR 025  = 0.62, IC 025  = 0.19, N  = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N  = 7; EudraVigilance, ROR 025  = 4.18, IC 025  = 1.02, N  = 5; JADER, ROR 025  = 1.05, IC 025  = 0.45, N  = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.

The Oncology Committee of the French Urology Association (CCAFU) is proposing a 2025 summary of recommendations' changes for the management of prostate cancer (PCa).

A systematic review of the literature from July 2024 to September 2025 was conducted by the CCAFU on the evolutions of diagnostic and therapeutic management of PCa evaluating the newly published references with their level of evidence.

Biparametric MRI is an alternative to multiparametric MRI imaging to guide biopsy decision making provided that a high-quality imaging and radiology expertise is achieved. Transperineal biopsy is the recommended approach when technically feasible. Whole-gland HIFU in patients fulfilling the HIFI trial criteria is a treatment option for intermediate-risk PCa patients. In case of metastasis-directed therapy outside the context of symptoms for oligometastatic hormone-sensitive PCa (mHSPC) disease, at least 6 months of androgen deprivation therapy (ADT) should be given. In patients with high-risk BCR treated according to the EMBARK criteria, systemic treatment with monotherapy enzalutamide may be considered. The ARPI used in addition to ADT alone can be: abiraterone, apalutamide, darolutamide, enzalutamide. In the case of HRR alterations, the combination of niraparib and abiraterone may be proposed as first-line mHSPC. In the case of a positive radiolabelled PSMA ligand PET/CT scan in a patient progressing after at least one ARPI, internal radiotherapy using [¹⁷⁷ Lu]LuPSMA-617 may be proposed. In patients with no or mildly symptomatic bone metastatic castration-resistant PCa without visceral metastases, the combination of enzalutamide+6 cycles of radium-223 may be proposed.

This 2025 summary of changes of French recommendations on PCa should help physicians to stay up-to-date with recent evolutions and aim to improve the management of PCa patients.