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NCT06957691 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Shehzad Basaria, M.D..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06957691 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that is actively recruiting participants, run by Shehzad Basaria, M.D.. The registered enrollment target is 60 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06957691, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Shehzad Basaria, M.D..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG fezolinetant - reference formulation
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-01-14 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06957691
The ClinicalTrials.gov registry entry for NCT06957691 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The listed sponsor is Shehzad Basaria, M.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06957691 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06957691 about?
NCT06957691 is a clinical study titled "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". 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 fezoli...
What is the current status of trial NCT06957691?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-01-14. Estimated completion is 2028-12-31.
What conditions does trial NCT06957691 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma, Prostate Carcinoma, Prostate Cancer (Adenocarcinoma), Prostate Neoplasm.
What interventions are being tested in trial NCT06957691?
The interventions under investigation include: Placebo (DRUG), fezolinetant - reference formulation (DRUG).
Who is sponsoring clinical trial NCT06957691?
This trial is sponsored by Shehzad Basaria, M.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06957691 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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