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Vasomotor SymptomsPhase 2NCT07568236

A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)

A Phase 2 study testing Fezolinetant in people with Vasomotor Symptoms and Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Vasomotor Symptoms, Prostate Cancer
What is being tested?
Fezolinetant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteHong Kong
Study dates
5 Oct 2026to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alex LIU, RCSEd, MBBS contact

35052625

alexliu@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • Prince of Wales Hospital

    Shatin

    Chi Fai NG, MD, 3505 2625, ngcf@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)

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.

Read the detailed description

Participants will be randomized in a 1:1 manner to receive fezolinetant 45 mg or placebo orally once daily for 12 weeks in total, with the primary and secondary outcomes being assessed at week 4, 8 and 12 with standardized questionnaires, symptom diaries, blood taking, and clinical history taking in the clinic setting.

Being tested
Fezolinetant, Placebo
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FezolinetantDrug

    Fezolinetant 45 mg orally once daily for 12 weeks.

  • PlaceboDrug

    Placebo orally once daily for 12 weeks.

Study groups in NCT07568236
Study groupRoleWhat they receive
Treatment ArmExperimentalFezolinetant 45 mg orally once daily for 12 weeks.
Receives: Drug: Fezolinetant
Placebo ArmPlacebo comparatorPlacebo orally once daily for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hot flush severity

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

    Measured: Baseline, week 3, week 7 and week 11

  2. 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.

    Measured: Baseline, week 3, week 7 and week 11

Secondary outcomes (6)

  1. Patient reported quality of life by QLQ-C30

    Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life

    Measured: Baseline, week 4, week 8 and week 12

  2. Sleep Quality

    By Pittsburgh Sleep Quality Index (PSQI). PSQI is scored by summing seven component scores (0-3 each) to produce a global score ranging from 0 to 21. A total score greater than 5 indicates poor sleep quality.

    Measured: Baseline, week 4, week 8 and week 12

  3. Mood status

    By Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item screening tool used to measure depression severity, with a total score ranging from 0 to 27. Scores are interpreted as: 0-4 (none-minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe).

    Measured: Baseline, week 4, week 8 and week 12

  4. Lower urinary tract symptoms (LUTS)

    Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)

    Measured: Baseline, week 4, week 8 and week 12

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

    HFRDIS) is a 10-item, self-report tool measuring how vasomotor symptoms (hot flashes) impact daily life over the past week. Scores are summed across 10 items on a 0-10 scale (total 0-100), with higher scores indicating greater interference. Validated cut-points for severity are mild (0-3.9), moderate (4-6.9), and severe (7-10)

    Measured: Baseline, week 4, week 8 and week 12

  6. Adverse Events

    CTCAE rectal toxicity, Grade 1-5 for any rectal toxicity, the higher the score the more severe the toxicity

    Measured: Baseline, Week 4, Week 8 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start5 Oct 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07568236
Sponsor's protocol ID
CRE-2025.427-T
Status last verified
Oct 2026
First submitted
21 Apr 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29928703

  • 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.

    PubMed 26584972

  • 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.

    PubMed 19963436

  • 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.

    PubMed 20552926

  • 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.

    PubMed 18294761

  • 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 36734148

  • 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.

    PubMed 38016166

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fezolinetant in people with Vasomotor Symptoms and Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alex LIU, RCSEd, MBBS (35052625, alexliu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hot flush severity (time frame: Baseline, week 3, week 7 and week 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07568236, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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