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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: Recruiting Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by Shehzad Basaria, M.D..
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Participants achieved a response if they had a significant decrease in scores in the hot flash diary.
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 |
What NCT06957691 shows while recruiting
NCT06957691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06957691's enrollment target sits among peer trials
60 421st of 735 higher than 293 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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