Fezolinetant for Hot Flashes in Prostate Cancer

(Fezo-ADT Trial)

Overseen By Elizabeth Borwick

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Shehzad Basaria, M.D.

Must be taking: Androgen deprivation

Must not be taking: Abiraterone, Docetaxel, Antidepressants, others

Disqualifiers: Liver cirrhosis, Low GFR, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether fezolinetant can reduce hot flashes in men with prostate cancer undergoing hormone therapy. Researchers aim to determine if it decreases the frequency and intensity of hot flashes and its effects on the liver, sleep, and mood. Participants will take either fezolinetant or a placebo daily for four weeks while tracking their hot flashes. Men with prostate cancer experiencing at least five moderate to severe hot flashes daily, and not on certain medications, may qualify for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, such as abiraterone acetate, docetaxel, some antidepressants, sedatives, and herbal compounds, to participate in this trial. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that fezolinetant is likely to be safe for humans?

Research shows that fezolinetant is generally safe. It is already approved for treating menopause-related hot flashes, providing some confidence in its safety. While researchers are testing it for men with prostate cancer, previous patients have tolerated the drug well. Reports indicate its unofficial use in prostate cancer patients, with careful follow-up needed to monitor side effects.

One study mentioned a man with prostate cancer who experienced a significant reduction in hot flashes using fezolinetant, suggesting it might work well without major safety issues. However, monitoring health closely, especially liver health, remains important, as the trial also aims to understand any possible liver-related side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hot flashes?

Fezolinetant is unique because it targets hot flashes in prostate cancer patients differently than standard hormone therapies. Unlike traditional treatments that often involve hormone manipulation, Fezolinetant works by blocking neurokinin-3 receptors, which are involved in regulating body temperature. This novel mechanism could offer relief without the hormonal side effects associated with existing therapies. Researchers are excited about Fezolinetant because it promises a non-hormonal approach, potentially improving quality of life for patients experiencing hot flashes due to prostate cancer treatment.

What evidence suggests that fezolinetant might be an effective treatment for hot flashes in prostate cancer?

Research has shown that fezolinetant, a drug approved for treating hot flashes in menopausal women, might also benefit men with prostate cancer who experience hot flashes due to hormone therapy. Studies have found that fezolinetant can reduce the number and intensity of hot flashes in women without using hormones, offering hope for men with similar issues. The drug blocks certain receptors in the brain that help control body temperature. In this trial, participants will receive either fezolinetant or a placebo to evaluate its effectiveness for hot flashes in men with prostate cancer. Although researchers are still studying fezolinetant's effectiveness for hot flashes in men with prostate cancer, its success in women suggests it could provide relief for men as well. ^{1 2 3 4 6}

Who Is on the Research Team?

Shehzad S Basaria, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

Men aged 40+ with prostate cancer experiencing at least 5 moderate to severe hot flashes daily while on androgen deprivation therapy. Participants must be able to sign informed consent.

Inclusion Criteria

I have been diagnosed with prostate cancer.

I am undergoing hormone therapy to lower testosterone levels.

I can sign the consent form myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take fezolinetant or a placebo daily for 4 weeks to assess the efficacy and safety in improving vasomotor symptoms

4 weeks

2 visits (in-person, every 2 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fezolinetant

Trial Overview

The trial is testing if fezolinetant can reduce the frequency and severity of hot flashes in men undergoing treatment for prostate cancer compared to a placebo, over a period of 4 weeks with bi-weekly clinic visits.

How Is the Trial Designed?

Group I: Fezolinetant Experimental Treatment 1 Intervention

Daily oral administration at a dose of 45 mg

Group II: Placebo Placebo Group 1 Intervention

Daily oral administration

Who Is Running the Clinical Trial?

Shehzad Basaria, M.D.

Lead Sponsor

Astellas Pharma US, Inc.

Industry Sponsor

Trials

90

Recruited

12,900+

Naoki Okamura

Astellas Pharma US, Inc.

Chief Executive Officer since 2023

Not available

Tadaaki Taniguchi

Astellas Pharma US, Inc.

Chief Medical Officer since 2023

MD, PhD

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06957691

Study Details | NCT06957691 | Proof-of-Concept Trial to ...

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11157406/

Could menopause drug fezolinetant show promise for ...

Whilst fezolinetant is currently only approved for menopause, its potential utility in prostate cancer and male hypogonadism is promising. Appropriate trials ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06972875

Fezolinetant for Treating Hot Flashes in Men With Prostate ...

The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved ...

4.

academic.oup.com

academic.oup.com/jcem/article/110/9/2509/8140119?rss=1

A Review of Hot Flash Management in Patients With Prostate ...

Hormonal therapies appear most effective for ameliorating VMS in men with prostate cancer experiencing bothersome hot flashes. Transdermal estradiol has been ...

5.

urotoday.com

urotoday.com/video-lectures/apccc-2024-conference-presentations-videos/video/4468-hot-flushes-how-can-we-help-our-patients-presentation-anthony-joshua.html

Hot Flushes – How Can We Help Our Patients? ...

And after five to eight years of therapy, 70% of men have hot flashes at five years—this is continuous ADT—reducing to 40% at eight years. So the hot flashes ...

6.

nejm.org

nejm.org/doi/abs/10.1056/NEJMc2412361

Neurokinin-3 Receptor Antagonism for Hot Flashes

A man with prostate cancer who was receiving androgen blockade had a substantial reduction in the frequency of hot flashes with the use of fezolinetant.