# 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

> **NCT06957691** · PHASE2 · RECRUITING · sponsor: **Shehzad Basaria, M.D.** · enrollment: 60 (estimated)

## Conditions studied

- 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

## Interventions

- **DRUG:** fezolinetant - reference formulation
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT06957691
- **Lead sponsor:** Shehzad Basaria, M.D.
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-01-14
- **Primary completion:** 2028-08-31
- **Final completion:** 2028-12-31
- **Target enrollment:** 60 (ESTIMATED)
- **Last updated:** 2026-03-09

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06957691

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-07-30 from https://api.ai-analytics.org/clinical/NCT06957691. Licensed CC0.

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