NCT06957691View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 31, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

December 31, 2028

Conditions
Prostate CancerProstate Cancer (Adenocarcinoma)Prostate Cancer Metastatic DiseaseProstate Cancer RecurrentProstate CarcinomaProstate NeoplasmProstate AdenocarcinomaProstate Cancer With Bone MetastasisVasomotor DisturbanceVasomotor SymptomsVasomotor Symptoms (VMS)Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenVasomotor Symptoms; Hot FlashesAndrogen Deprivation TherapyAndrogen Ablative Therapy of Advanced Hormone-dependent Prostate CarcinomaAndrogen-deprivation TherapyHot FlashesHot FlushesHot Flushes and/or Sweats
Interventions
DRUG

fezolinetant - reference formulation

Daily oral administration of fezolinetant at a dose of 45 mg

DRUG

Placebo

Daily oral administration of placebo

All Listed Sponsors
collaborator

Astellas Pharma US, Inc.

INDUSTRY

lead

Shehzad Basaria, M.D.

OTHER

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 | Biotech Hunter | Biotech Hunter