A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes. There is an unmet medical need to treat hot flashes in men undergoing hormone therapy for prostate cancer. This study will help researchers understand if hormone therapy (enzalutamide, apalutamide or bicalutamide) affects the way fezolinetant is processed by the body in men with prostate cancer. The main aim of this study is checking levels of fezolinetant in the blood over tim

Trial Details

NCT ID

NCT07783282

Phase

PHASE1

Sponsor

Astellas Pharma Global Development, Inc.

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

fezolinetant
enzalutamide
apalutamide
bicalutamide
GnRH agonist/antagonist

Locations (sample)

Plovdiv, Plovdiv Province, Bulgaria|42.15387,24.75001

Key Eligibility Criteria

Participant is born male, inclusive of all gender ideologies.
Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the …
Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investiga…
Male participant must not donate sperm during the treatment period and for 30 days after final study intervention administration.

For full eligibility, visit ClinicalTrials.gov.

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