Prostate CancerPhase 2Fezo-ADTNCT06957691
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 testing fezolinetant - reference formulation in people with Prostate Cancer and Prostate Cancer (Adenocarcinoma), run by Shehzad Basaria, M.D. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer (Adenocarcinoma), Prostate Cancer Metastatic Disease
- What is being tested?
- fezolinetant - reference formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2026to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male sex
- Age 40 years and older
- Diagnosis of prostate cancer
- Androgen deprivation therapy
- Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week
- Ability to sign the inform consent
- Willing to use reliable methods of contraception if partner is of childbearing age
- Ability to record hot flashes electronically
Who cannot join
- 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
- Total bilirubin above the upper limit of normal
- Glomerular filtration rate < 30 mL/min
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- Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics if prescribed for the treatment of hot flashes
- Use of over-the-counter hormonal agents or herbal compounds
- Current use of CYP1A2 inhibitors
- Ingestion of alcohol within 2 weeks prior to the baseline visit
- Inability to abstain from alcohol use during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Caroline Veteri, 617-525-8407, cveteri@bwh.harvard.edu
Shehzad Basaria, MD
About this study
Official 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 (Fezo-ADT 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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Prostate Cancer, Prostate Cancer (Adenocarcinoma), Prostate Cancer Metastatic Disease, Prostate Cancer Recurrent, Prostate Carcinoma, Prostate Neoplasm
- Being tested
- fezolinetant - reference formulation, Placebo
- Keywords
- Androgen Deprivation Therapy, Hot Flashes, Hot Flushes, Prostate Cancer, Vasomotor Symptoms
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Multiple Endocrine Neoplasia Type 1, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fezolinetant - reference formulationDrug
Daily oral administration of fezolinetant at a dose of 45 mg
PlaceboDrug
Daily oral administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| Fezolinetant | Experimental | Daily oral administration at a dose of 45 mg Receives: Drug: fezolinetant - reference formulation |
| Placebo | Placebo comparator | Daily oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to the end of treatment at 4 weeks.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to the end of treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start14 Jan 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shehzad Basaria, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor-investigator, Shehzad Basaria, M.D., Brigham and Women's Hospital
- Investigators
- Shehzad S Basaria, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957691
- Sponsor's protocol ID
- GR1000264
- Acronym
- Fezo-ADT
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, Thurston RC, Wolfman W, English M, Franklin C, Lee M, Santoro N. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981-1997. doi: 10.1210/clinem/dgad058.
PubMed 36734148Lederman S, Ottery FD, Cano A, Santoro N, Shapiro M, Stute P, Thurston RC, English M, Franklin C, Lee M, Neal-Perry G. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. Lancet. 2023 Apr 1;401(10382):1091-1102. doi: 10.1016/S0140-6736(23)00085-5. Epub 2023 Mar 13.
PubMed 36924778Patel B, S Dhillo W. Menopause review: Emerging treatments for menopausal symptoms. Best Pract Res Clin Obstet Gynaecol. 2022 May;81:134-144. doi: 10.1016/j.bpobgyn.2021.10.010. Epub 2021 Nov 17.
PubMed 34965909Sharma P, Wisniewski A, Braga-Basaria M, Xu X, Yep M, Denmeade S, Dobs AS, DeWeese T, Carducci M, Basaria S. Lack of an effect of high dose isoflavones in men with prostate cancer undergoing androgen deprivation therapy. J Urol. 2009 Nov;182(5):2265-72. doi: 10.1016/j.juro.2009.07.030. Epub 2009 Sep 16.
PubMed 19758646Harle LK, Maggio M, Shahani S, Braga-Basaria M, Basaria S. Endocrine complications of androgen-deprivation therapy in men with prostate cancer. Clin Adv Hematol Oncol. 2006 Sep;4(9):687-96.
PubMed 17099626Hunter MS, Stefanopoulou E. Vasomotor symptoms in prostate cancer survivors undergoing androgen deprivation therapy. Climacteric. 2016;19(1):91-7. doi: 10.3109/13697137.2015.1125460. Epub 2015 Dec 16.
PubMed 26673756Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
PubMed 36633525Lee A. Fezolinetant: First Approval. Drugs. 2023 Aug;83(12):1137-1141. doi: 10.1007/s40265-023-01917-1.
PubMed 37462862Rance NE, Young WS 3rd. Hypertrophy and increased gene expression of neurons containing neurokinin-B and substance-P messenger ribonucleic acids in the hypothalami of postmenopausal women. Endocrinology. 1991 May;128(5):2239-47. doi: 10.1210/endo-128-5-2239.
PubMed 1708331Modi M, Dhillo WS. Neurokinin 3 Receptor Antagonism: A Novel Treatment for Menopausal Hot Flushes. Neuroendocrinology. 2019;109(3):242-248. doi: 10.1159/000495889. Epub 2018 Nov 30.
PubMed 30504731Depypere H, Lademacher C, Siddiqui E, Fraser GL. Fezolinetant in the treatment of vasomotor symptoms associated with menopause. Expert Opin Investig Drugs. 2021 Jul;30(7):681-694. doi: 10.1080/13543784.2021.1893305. Epub 2021 Jul 12.
PubMed 33724119Skorupskaite K, George JT, Veldhuis JD, Millar RP, Anderson RA. Neurokinin 3 Receptor Antagonism Reveals Roles for Neurokinin B in the Regulation of Gonadotropin Secretion and Hot Flashes in Postmenopausal Women. Neuroendocrinology. 2018;106(2):148-157. doi: 10.1159/000473893. Epub 2017 Apr 5.
PubMed 28380486Stearns V. Management of hot flashes in breast cancer survivors and men with prostate cancer. Curr Oncol Rep. 2004 Jul;6(4):285-90. doi: 10.1007/s11912-004-0037-y.
PubMed 15161582Guise TA, Oefelein MG, Eastham JA, Cookson MS, Higano CS, Smith MR. Estrogenic side effects of androgen deprivation therapy. Rev Urol. 2007 Fall;9(4):163-80.
PubMed 18231613Naoe M, Ogawa Y, Shichijo T, Fuji K, Fukagai T, Yoshida H. Pilot evaluation of selective serotonin reuptake inhibitor antidepressants in hot flash patients under androgen-deprivation therapy for prostate cancer. Prostate Cancer Prostatic Dis. 2006;9(3):275-8. doi: 10.1038/sj.pcan.4500891. Epub 2006 Jun 20.
PubMed 16786037