NCT07568236

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
21mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Vasomotor SymptomsProstate Cancer

Outcome Measures

Primary Outcomes (2)

  • Hot flush severity

    Participants will document daily VMS episodes categorised as mild, moderate, severe, or very severe.

    Baseline, week 3, week 7 and week 11

  • Daily hot flush score

    Calculatedusing the formula: (1 × mild) + (2 × moderate) + (3 × severe) + (4 × very severe) divided by the number of diary days completed in that week.

    Baseline, week 3, week 7 and week 11

Secondary Outcomes (6)

  • Patient reported quality of life by QLQ-C30

    Baseline, week 4, week 8 and week 12

  • Sleep Quality

    Baseline, week 4, week 8 and week 12

  • Mood status

    Baseline, week 4, week 8 and week 12

  • Lower urinary tract symptoms (LUTS)

    Baseline, week 4, week 8 and week 12

  • Patient reported quality of life by Hot Flash-Related Daily Interference Scale (HFRDIS)

    Baseline, week 4, week 8 and week 12

  • +1 more secondary outcomes

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Fezolinetant 45 mg orally once daily for 12 weeks.

Drug: Fezolinetant

Placebo Arm

PLACEBO COMPARATOR

Placebo orally once daily for 12 weeks.

Drug: Placebo

Interventions

FezolinetantDRUG

Fezolinetant 45 mg orally once daily for 12 weeks.

Treatment Arm
PlaceboDRUG

Placebo orally once daily for 12 weeks.

Placebo Arm

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged at least 18 years old on the index date
  • Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease
  • Karnofsky index score of 70% or more
  • Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline
  • Baseline daily hot flush score ≥4

You may not qualify if:

  • Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine
  • Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.
  • Active liver disease including:
  • \- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT / AST - abnormal INR
  • Severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (7)

  • Challapalli A, Edwards SM, Abel P, Mangar SA. Evaluating the prevalence and predictive factors of vasomotor and psychological symptoms in prostate cancer patients receiving hormonal therapy: Results from a single institution experience. Clin Transl Radiat Oncol. 2018 Mar 21;10:29-35. doi: 10.1016/j.ctro.2018.03.002. eCollection 2018 Mar.

    PMID: 29928703BACKGROUND

  • Teleni L, Chan RJ, Chan A, Isenring EA, Vela I, Inder WJ, McCarthy AL. Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials. Endocr Relat Cancer. 2016 Feb;23(2):101-12. doi: 10.1530/ERC-15-0456. Epub 2015 Nov 19.

    PMID: 26584972BACKGROUND

  • Irani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncol. 2010 Feb;11(2):147-54. doi: 10.1016/S1470-2045(09)70338-9. Epub 2009 Dec 4.

    PMID: 19963436BACKGROUND

  • Moraska AR, Atherton PJ, Szydlo DW, Barton DL, Stella PJ, Rowland KM Jr, Schaefer PL, Krook J, Bearden JD, Loprinzi CL. Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB. J Support Oncol. 2010 May-Jun;8(3):128-32.

    PMID: 20552926BACKGROUND

  • Frisk J, Spetz AC, Hjertberg H, Petersson B, Hammar M. Two modes of acupuncture as a treatment for hot flushes in men with prostate cancer--a prospective multicenter study with long-term follow-up. Eur Urol. 2009 Jan;55(1):156-63. doi: 10.1016/j.eururo.2008.02.002. Epub 2008 Feb 14.

    PMID: 18294761BACKGROUND

  • 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.

    PMID: 36734148BACKGROUND

  • Morga A, Ajmera M, Gao E, Patterson-Lomba O, Zhao A, Mancuso S, Siddiqui E, Kagan R. Systematic review and network meta-analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause. Menopause. 2024 Jan 1;31(1):68-76. doi: 10.1097/GME.0000000000002281. Epub 2023 Nov 27.

    PMID: 38016166BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

fezolinetant

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Chi Fai NG, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex LIU, RCSEd, MBBS

CONTACT

35052625alexliu@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 5, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)