Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Men aged 18 or older who are currently receiving Androgen Deprivation Therapy (ADT) for prostate cancer — this includes men who have had surgical removal of the testicles, or who are taking hormone-blocking injections or pills (such as leuprolide, degarelix, or relugolix).
• Men who are also taking additional hormone-blocking medications known as ARPIs (such as abiraterone, enzalutamide, apalutamide, or darolutamide).
• Men who have been on a stable, unchanged dose of all their hormone therapies for at least 28 days before joining, and who are not planning to stop these therapies for at least 42 days after joining.
• Men who are receiving radiation therapy during the study period.
• Men who have been experiencing bothersome hot flashes for at least 7 days before signing consent, with an average of four or more hot flashes per day that are severe enough to prompt seeking treatment.
• Men with a life expectancy of 6 months or more.
• Men who are able to speak and read English, as some required questionnaires must be completed in English.

Who may not be able to join:

• Men who are currently using, or planning to use during the study, any medication not approved by the FDA for use in humans, any drug that has a category X interaction with fezolinetant, or any hormone or complementary/alternative medicine taken specifically to manage hot flashes (such as androgens, estrogens, or progesterone-type medications) — though prior use is acceptable if stopped before joining.
• Men currently taking certain liver-processed medications called CYP1A2 inhibitors (confirm with trial site for a list of specific medications).
• Men with a history of cirrhosis (serious scarring of the liver).
• Men with certain abnormal liver blood test results — specifically, liver enzyme levels (ALT or AST) at two or more times the upper limit of normal, or elevated bilirubin levels above the normal range.
• Men with significantly reduced kidney function, defined as an eGFR below 30 mL/min/1.73m² (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.