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

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.

Sex

Male

Minimum age

18 Years

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)

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• BACKGROUNDTeleni L, Chan RJ, Chan A, Isenring EA, Vela I, Inder WJ, McCarthy AL. Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials. Endocr Relat Cancer. 2016 Feb;23(2):101-12. doi: 10.1530/ERC-15-0456. Epub 2015 Nov 19. PMID 26584972
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• BACKGROUNDJohnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, Thurston RC, Wolfman W, English M, Franklin C, Lee M, Santoro N. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981-1997. doi: 10.1210/clinem/dgad058.