Health TrialsbyHealthPanel

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

ConditionsProstate 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
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorShehzad Basaria, M.D.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male sex

Age 40 years and older

Diagnosis of prostate cancer

Androgen deprivation therapy

Disqualifiers

Use of abiraterone acetate

Use of docetaxel and other chemotherapeutic agents

Liver cirrhosis

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal

Trial design

Design model

Parallel

Treatments tested in this trial

  • fezolinetant - reference formulation

    Drug

    Daily oral administration of fezolinetant at a dose of 45 mg

  • Placebo

    Drug

    Daily oral administration of placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: FezolinetantExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the Frequency of Vasomotor Symptoms Through Daily Hot Flash Diary from Baseline to 4 Weeks

Participants achieved a response if they had a significant decrease in scores in the hot flash diary.

Time frame
From baseline to the end of treatment at 4 weeks.
2

Hepatic safety, as assessed by measuring liver function tests

Fezolinetant was considered safe if liver function tests did not change significantly.

Time frame
From baseline to the end of treatment at 4 weeks.

Secondary outcomes

1

Change in quality-of-life symptoms related to hot flashes, as assessed using the Hot Flash-Related Daily Interference Scale

The Hot Flash-Related Daily Interference Scale scores range from 0 to 10, with higher scores meaning a worse outcome. Participants improved if they had a significant decrease in their Hot Flash-Related Daily Interference Scale scores.

Time frame
From baseline to the end of treatment at 4 weeks.
2

Change in overall quality of life, as assessed using the Short Form-36 questionnaire

The Short Form-36 scores range from 0 to 100, with higher scores meaning a better outcome. Participants improved if they had a significant increase in their Short Form-36 scores.

Time frame
From baseline to the end of treatment at 4 weeks.
3

Change in sleep quality, as assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance questionnaire

The Patient-Reported Outcomes Measurement Information System Sleep Disturbance scores range from about 30 to 80, with lower scores meaning better outcome. Patients improved if they had a significant decrease in Patient-Reported Outcomes Measurement Information System Sleep Disturbance scores.

Time frame
From baseline to the end of treatment at 4 weeks.
4

Change in mood, as assessed using the Positive and Negative Affect Schedule questionnaire

The Positive and Negative Affect Schedule questionnaire measures two dimensions of mood, Positive Affect and Negative Affect. The scores in each dimension range from 10 to 50. A higher score in the Positive Affect dimension means a better outcome, and a higher score in the Negative Affect dimension means a worse outcome. Participants improved if they had a significant increase in the Positive Affect dimension scores and a significant decrease in the Negative Affect dimension scores in the Positive and Negative Affect Schedule questionnaire.

Time frame
From baseline to the end of treatment at 4 weeks.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shehzad Basaria, M.D.

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

Astellas Pharma US, Inc.

Collaborator

Source ClinicalTrials.gov
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