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 ID: NCT06957691
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2026-01-14
2028-12-31
Brief Summary
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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
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fezolinetant
Daily oral administration at a dose of 45 mg
fezolinetant - reference formulation
Daily oral administration of fezolinetant at a dose of 45 mg
Placebo
Daily oral administration
Placebo
Daily oral administration of placebo
Interventions
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fezolinetant - reference formulation
Daily oral administration of fezolinetant at a dose of 45 mg
Placebo
Daily oral administration of placebo
Eligibility Criteria
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Inclusion Criteria
* Age 40 years and older
* Diagnosis of prostate cancer
* Androgen deprivation therapy
* Presence of 5 or more hot flashes a day that are considered moderate to severe
* 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
Exclusion Criteria
* 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
* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics
* 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.
40 Years
MALE
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Shehzad Basaria, M.D.
OTHER
Responsible Party
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Shehzad Basaria, M.D.
Professor of Medicine
Principal Investigators
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Shehzad S Basaria, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Elizabeth Borwick
Role: primary
References
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Patel 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.
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.
Lederman 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.
Sharma 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.
Harle 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.
Hunter 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.
Siegel 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.
Lee A. Fezolinetant: First Approval. Drugs. 2023 Aug;83(12):1137-1141. doi: 10.1007/s40265-023-01917-1.
Rance 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.
Modi 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.
Depypere 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.
Skorupskaite 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.
Stearns 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.
Guise 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.
Naoe 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.
Russell N, Hoermann R, Cheung AS, Ching M, Zajac JD, Handelsman DJ, Grossmann M. Short-term effects of transdermal estradiol in men undergoing androgen deprivation therapy for prostate cancer: a randomized placebo-controlled trial. Eur J Endocrinol. 2018 May;178(5):565-576. doi: 10.1530/EJE-17-1072. Epub 2018 Mar 16.
Freedland SJ, Eastham J, Shore N. Androgen deprivation therapy and estrogen deficiency induced adverse effects in the treatment of prostate cancer. Prostate Cancer Prostatic Dis. 2009;12(4):333-8. doi: 10.1038/pcan.2009.35. Epub 2009 Sep 1.
Sharifi N, Gulley JL, Dahut WL. Androgen deprivation therapy for prostate cancer. JAMA. 2005 Jul 13;294(2):238-44. doi: 10.1001/jama.294.2.238.
Related Links
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Highlights of Prescribing Information. VEOZAH® (fezolinetant) tablets, for oral use. Approval: 2023. Revised: 12/2024
Other Identifiers
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GR1000264
Identifier Type: -
Identifier Source: org_study_id