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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Shehzad Basaria, M.D.
Study ID
NCT06957691
Phase
PHASE2
Status
Recruiting
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Conditions

  • Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
  • Androgen Deprivation Therapy
  • Androgen-deprivation Therapy
  • Hot Flashes
  • Hot Flushes
  • Hot Flushes and/or Sweats
  • Prostate Adenocarcinoma
  • Prostate Cancer
  • Prostate Cancer (Adenocarcinoma)
  • Prostate Cancer Metastatic Disease
  • Prostate Cancer Recurrent
  • Prostate Cancer With Bone Metastasis
  • Prostate Carcinoma
  • Prostate Neoplasm
  • Vasomotor Disturbance
  • Vasomotor Symptoms
  • Vasomotor Symptoms (VMS)
  • Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
  • Vasomotor Symptoms; Hot Flashes

Eligibility Criteria

Sex
MALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fezolinetant - reference formulation — DRUG
    Daily oral administration of fezolinetant at a dose of 45 mg
  • Placebo — DRUG
    Daily oral administration of placebo

Study Details

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy. The main questions it aims to answer are: * Does fezolinetant improve the frequency and severity of hot flashes? * Does fezolinetant cause any harm to the liver? * Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters? Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine. Participants will: * Take fezolinetant or a placebo every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes

Key Dates

Start date
Jan 14, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fezolinetant
    Daily oral administration at a dose of 45 mg
  • Placebo Comparator: Placebo
    Daily oral administration

Primary Outcome Measure

Change in the Frequency of Vasomotor Symptoms Through Daily Hot Flash Diary from Baseline to 4 Weeks [ Time Frame: From baseline to the end of treatment at 4 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Elizabeth Borwick
[email protected]
617-525-8407
Shehzad Basaria, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
MenopauseProstate cancer
By specialty
Women's healthFertilityOncologyProstate oncologyMen's healthUrology
By research site
Brigham and Women's Hospital· Boston, MA

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