← Landscape

Trial NCT06957691

Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

Phase
Phase 2
Sponsor
Shehzad Basaria, M.D.
Conditions
Prostate Cancer; Prostate Cancer (Adenocarcinoma); Prostate Cancer Metastatic Disease; Prostate Cancer Recurrent; Prostate Carcinoma; Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer With Bone Metastasis; Vasomotor Disturbance; Vasomotor Symptoms; Vasomotor Symptoms (VMS); Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men; Vasomotor Symptoms; Hot Flashes; Androgen Deprivation Therapy; Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma; Androgen-deprivation Therapy; Hot Flashes; Hot Flushes; Hot Flushes and/or Sweats
Ages
40+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Male sex * Age 40 years and older * Diagnosis of prostate cancer * Androgen deprivation therapy * Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week * Ability to sign the inform consent * Willing to use reliable methods of contraception if partner is of childbearing age * Ability to record hot flashes electronically Exclusion Criteria: * Use of abiraterone acetate * Use of docetaxel and other chemotherapeutic agents * Liver cirrhosisHepatic * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal * Total bilirubin above the upper limit of normal * Glomerular filtration rate < 30 mL/minRenal * Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics if prescribed for the treatment of hot flashes * Use of over-the-counter hormonal agents or herbal compounds * Current use of CYP1A2 inhibitors * Ingestion of alcohol within 2 weeks prior to the baseline visit * Inability to abstain from alcohol use during the study period.

Restrictions found (2)

Recruiting in Massachusetts

  • Brigham and Women's Hospital · Boston, Suffolk County