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
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)
- HepaticOutrightexclusionShow in the text
- RenalOutrightexclusion
GFR < 30 mL/min
Show in the text
Recruiting in Massachusetts
- Brigham and Women's Hospital · Boston, Suffolk County