Trial · 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
NCT06957691, Phase 2, Recruiting, Shehzad Basaria, M.D.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT06957691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06957691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT06957691
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Shehzad Basaria, M.D.
- Conditions
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
- fezolinetant - reference formulation, Placebo
- First posted
- 2025-05-04
- Last updated
- 2026-08-17
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Frequency of Vasomotor Symptoms Through Daily Hot Flash Diary from Baseline to 4 Weeks | From baseline to the end of treatment at 4 weeks. | Participants achieved a response if they had a significant decrease in scores in the hot flash diary. |
| Primary | Hepatic safety, as assessed by measuring liver function tests | From baseline to the end of treatment at 4 weeks. | Fezolinetant was considered safe if liver function tests did not change significantly. |
| Secondary | Change in quality-of-life symptoms related to hot flashes, as assessed using the Hot Flash-Related Daily Interference Scale | From baseline to the end of treatment at 4 weeks. | 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. |
| Secondary | Change in overall quality of life, as assessed using the Short Form-36 questionnaire | From baseline to the end of treatment at 4 weeks. | 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. |
| Secondary | Change in sleep quality, as assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance questionnaire | From baseline to the end of treatment at 4 weeks. | 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. |
| Secondary | Change in mood, as assessed using the Positive and Negative Affect Schedule questionnaire | From baseline to the end of treatment at 4 weeks. | 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. |
| Secondary | Change in sexual function, as assessed using the Sexual Arousal, Interest and Drive questionnaire | From baseline to the end of treatment at 4 weeks. | The Sexual Arousal, Interest and Drive questionnaire scores range from 0 to 100, with higher scores meaning better outcome. Participants improved if they had a significant increase in Sexual Arousal, Interest and Drive scores. |
| Secondary | Change in inflammatory status, as assessed by measuring high-sensitivity C-reactive protein (hsCRP) levels | From baseline to the end of treatment at 4 weeks. | Participants improved if they had a significant decrease in high-sensitivity C-reactive protein (hsCRP) levels. |
| Secondary | Change in fatigue, as assessed using the using the Hypogonadism Energy Diary questionnaire | From baseline to the end of treatment at 4 weeks. | The Hypogonadism Energy Diary scores range from 0 to 100, with higher scores meaning better outcome. Participants improved if they had a significant increase in Hypogonadism Energy Diary scores. |
| Secondary | Change in fatigue, as assessed using the using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire | From baseline to the end of treatment at 4 weeks. | The Functional Assessment of Chronic Illness Therapy - Fatigue scores range from 0 to 160, with higher scores meaning better outcome. Participants improved if they had a significant increase in Functional Assessment of Chronic Illness Therapy - Fatigue scores. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06957691
GET https://conductscience.org/api/trials/v1/NCT06957691/registered