A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)

Inclusion Criteria: 1. Patients aged at least 18 years old on the index date 2. Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease 3. Karnofsky index score of 70% or more 4. Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline 5. Baseline daily hot flush score ≥4 Exclusion Criteria: 1. Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine 2. Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc. 3. Active liver disease including: \- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT / AST - abnormal INR 4. Severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2)