Condition: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06957691

Sponsor: Shehzad Basaria, M.D.

Phase: Phase 2

Eligibility:

• Age: minimum 40 Years maximum N/A
• Gender: Male

Inclusion Criteria:

• Male sex
• Age 40 years and older
• Diagnosis of prostate cancer
• Androgen deprivation therapy
• Presence of 5 or more hot flashes a day that are considered moderate to severe
• 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 cirrhosis
• 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/min
• Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics
• 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.

View trial on ClinicalTrials.gov