A Phase 2 interventional study of fezolinetant - reference formulation and Placebo in Prostate Cancer, Prostate Cancer (Adenocarcinoma) and Prostate Cancer Metastatic Disease, sponsored by Shehzad Basaria, M.D.. Recruiting at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Shehzad Basaria, M.D. · Phase 2, Interventional, and Treatment
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:
Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.
Participants will:
Prostate cancer is the most common type of cancer in men. At the time of initial diagnosis, most men have disease that is confined to the prostate and are typically managed through surveillance or local treatments, such as prostatectomy or radiation therapy. Since the prostate relies on androgens (male hormones), androgen deprivation therapy is the primary treatment for patients with locally advanced, recurrent, or metastatic prostate cancer.
Androgen deprivation therapy involves suppressing the production of androgens in men, which can be achieved through orchiectomy (removal of the testes) or medications like gonadotropin-releasing hormone agonists or antagonists that lower serum testosterone levels to a castrate range (less than 20 ng/dL). In men, 95% of serum estrogen comes from the aromatization of testosterone. Consequently, androgen deprivation not only leads to androgen deficiency but also results in near-absolute estrogen deficiency. The absence of sex hormones in these patients can cause numerous adverse effects, including sexual dysfunction, and loss of muscle and bone. Among these side effects, vasomotor symptoms (such as hot flashes) are particularly debilitating. These symptoms are characterized by sudden feelings of intense heat that spread throughout the body, prompting the activation of heat-dissipation mechanisms to lower body temperature.
Hot flashes are reported by 70-80% of men undergoing androgen deprivation therapy, typically beginning a few weeks after treatment starts, with most men experiencing more than five episodes daily. These vasomotor symptoms significantly affect the patient's quality of life, sleep quality, concentration, and overall productivity. Despite the burden they impose, effective treatments for hot flashes in men undergoing androgen deprivation therapy are still lacking.
The introduction of neurokinin 3 (NK3) receptor antagonists has brought hope to this area. Fezolinetant is a selective NK3 receptor antagonist that has recently been approved for treating moderate to severe vasomotor symptoms in menopausal women. Given that the underlying cause of vasomotor symptoms in both menopausal women and men on androgen deprivation therapy stems from estrogen deficiency, fezolinetant offers an opportunity to assess its efficacy and safety for male patients.
No previous studies have evaluated the effectiveness of NK3 receptor antagonists on vasomotor symptoms in men undergoing androgen deprivation therapy for prostate cancer. Since prostate cancer is the most prevalent solid tumor in men and vasomotor symptoms are common, distressing, and highly burdensome, a trial demonstrating the safety and efficacy of fezolinetant could provide clinicians and patients with a novel, effective, safe, and easy-to-administer treatment that has the potential to transform care for these patients.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Shehzad Basaria, M.D. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily oral administration at a dose of 45 mg
Drug: fezolinetant - reference formulation
Daily oral administration
Drug: Placebo
Daily oral administration of fezolinetant at a dose of 45 mg
Daily oral administration of placebo
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.
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.
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.
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.
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.
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.
Change in sexual function, as assessed using the Sexual Arousal, Interest and Drive questionnaire
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Change in inflammatory status, as assessed by measuring high-sensitivity C-reactive protein (hsCRP) levels
Participants improved if they had a significant decrease in high-sensitivity C-reactive protein (hsCRP) levels.
Time frame: From baseline to the end of treatment at 4 weeks.
Change in fatigue, as assessed using the using the Hypogonadism Energy Diary questionnaire
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Change in fatigue, as assessed using the using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire
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.
Time frame: From baseline to the end of treatment at 4 weeks.
Change in fasting glucose level
Participants improved if they had a significant decrease in fasting glucose level.
Time frame: From baseline to the end of treatment at 4 weeks.
Change in glycated hemoglobin (HbA1c) level
Participants improved if they had a significant decrease in glycated hemoglobin (HbA1c) level.
Time frame: From baseline to the end of treatment at 4 weeks.
Change in fasting lipid levels
Participants improved if they had a significant decrease in fasting lipid levels.
Time frame: From baseline to the end of treatment at 4 weeks.
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