Study of luxdegalutamide and abiraterone combination in adult men with metastatic hormone-sensitive prostate cancer

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What is this study about?

This study focuses on metastatic hormone-sensitive prostate cancer, a condition where cancer has spread beyond the prostate and still responds to hormone therapy. The research evaluates a new treatment combination using luxdegalutamide (also known as JSB462) together with abiraterone. These medications work by blocking male hormones that can stimulate cancer growth.

The study compares different doses of luxdegalutamide (100 mg or 300 mg daily) combined with abiraterone against standard hormone therapy. Participants will also receive medications to lower testosterone levels, either through degarelix injections or other similar drugs. The treatment continues for several months to determine which dose combination works best while monitoring safety and effectiveness.

Throughout the study, doctors will track how well the treatment works by measuring PSA (prostate-specific antigen) levels in the blood and using imaging tests to check if the cancer is shrinking. They will also monitor any side effects and how well patients tolerate the treatment. The study aims to find the most effective and safest dose combination to help treat this type of prostate cancer.

1 Initial Assessment

Your eligibility for the study will be confirmed based on the following criteria:

– Confirmation of metastatic hormone-sensitive prostate cancer

– Verification of your physical condition using the ECOG Performance Status scale (must be 2 or less)

– Confirmation of prostate adenocarcinoma through tissue examination

– Presence of specific metastases: either 1 or more metastases in internal organs, or 4 or more bone metastases

– Your testosterone level must be below 50 ng/dL

2 Treatment Assignment

You will be randomly assigned to one of the treatment groups:

Group 1: Luxdegalutamide (100 mg daily) with abiraterone

Group 2: Luxdegalutamide (300 mg daily) with abiraterone

Group 3: Standard treatment (control group)

3 Treatment Period

The medication will be taken orally each day

Regular assessments will include:

– Blood tests to measure PSA levels

– Imaging scans to monitor disease progression

– Physical examinations

– Monitoring of side effects

– Quality of life assessments

4 Follow-up Monitoring

Regular monitoring will continue until May 2032

The following will be tracked:

– Changes in your condition

– Response to treatment

– Any side effects

– Overall survival

Who Can Join the Study?

Must be a male aged 18 years or older
Must have a performance status score of ECOG (a measure of daily living abilities) of 2 or less
Must have confirmed prostate adenocarcinoma (a type of prostate cancer). Patients with mixed cancer types including neuroendocrine features are not eligible
Must have high-volume metastatic hormone-sensitive prostate cancer, which means either:
- At least 1 cancer spread to internal organs (excluding lymph nodes), or
- At least 4 bone lesions with at least one located outside the spine or pelvis
Must have imaging tests (CT, MRI, or bone scan) performed within 28 days before starting the study
Must have testosterone levels below 50 ng/dL or 1.7 nmol/L (castrate level)
Can be receiving hormone therapy (ADT) for up to 90 days before study start, as long as PSA levels haven’t dropped below 0.2 ng/ml
Hormone therapy can include either:
- Previous surgical removal of testicles (orchiectomy), or
- Ongoing hormone-blocking medications (GnRH analog/antagonist)

Who Cannot Join the Study?

Prior treatment with any androgen receptor pathway inhibitors (ARPI) – medications that block male hormones
History of seizures or conditions that may cause seizures
Active or untreated brain or spinal cord metastases (cancer that has spread to brain or spine)
Severe heart conditions including heart failure, uncontrolled high blood pressure, or recent heart attack
Significant liver problems or abnormal liver function tests
Active or chronic infections including hepatitis B, hepatitis C, or HIV
Other active cancers within the past 3 years (except certain skin cancers)
Major surgery within 4 weeks before starting the study
Participation in other clinical trials within 4 weeks before this study
Any condition that could interfere with taking oral medications
Known allergic reactions to study medications or similar compounds
Psychological, social or medical conditions that could interfere with study participation
Use of certain medications that could interact with study drugs
Uncontrolled diabetes or other serious medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centre Antoine Lacassagne	Nice	France
Hospital Foch	Suresnes	France
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Isala Klinieken Stichting	Zwolle	The Netherlands
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR	Nuertingen	Germany
Albert Schweitzer Ziekenhuis	Dordrecht	The Netherlands
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Ospedale Cardinal Massaia	Asti	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Capio La Croix Du Sud	Quint-Fonsegrives	France
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
Hospital Universitario Lucus Augusti	Lugo	Spain
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
University Hospital Olomouc	Olomouc	Czechia
Hopital Beaujon	Clichy	France
Spaarne Gasthuis	Hoofddorp	The Netherlands
Fwbwsz 2 Sdl z oews	Oświęcim	Poland
Ubnepzwjxz Mxrztww Cyaqfv Hhjjgllubovnstije	Hamburg	Germany
Hnfacbyp Umhsgbdngcuxk Mtbnhft Db Vdenzqtwnx	Santander	Spain
Hmxxbdqs Uzgcxnglgcfyy Dr Bdqmqzm	Badajoz	Spain
Izatoqjf Mlvqjvwfrc Mmoatmoaun	Paris	France
Axvhual Sxx z oeom	Poznan	Poland
Fwqawtsv nzuiewflw Mzsgv a Hjggbbw	Prague	Czechia
Ucnurrtldtfoujvwloagt Dvlsbpkxidq Avg	Duesseldorf	Germany
Iwnmoryv Pftattpovyfqvxc Cxjpeb Cucniy	Marseille	France

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	28.11.2025
France	Recruiting	28.11.2025
Germany	Recruiting	28.11.2025
Italy	Recruiting	28.11.2025
Poland	Recruiting	28.11.2025
Spain	Recruiting	28.11.2025
The Netherlands	Recruiting	28.11.2025

Trial locations

Investigated drugs:

JSB462 (luxdegalutamide) is a new investigational medication being studied for treating prostate cancer. It belongs to a class of drugs that target male hormones to help fight cancer cells. This medication is being tested in combination with other treatments to see if it can help patients with metastatic prostate cancer that still responds to hormone therapy.

Abiraterone is an established medication used to treat prostate cancer. It works by blocking the production of male hormones (androgens) throughout the body, which can help slow down or stop the growth of prostate cancer cells. This medication is typically taken as a pill along with a steroid medication.

ARPI (Androgen Receptor Pathway Inhibitor) refers to a class of medications that block the effects of male hormones on prostate cancer cells. This serves as the control treatment in this study, representing the current standard of care for patients with metastatic hormone-sensitive prostate cancer.

Metastatic hormone-sensitive prostate cancer – A type of prostate cancer that has spread beyond the prostate gland to other parts of the body but still responds to hormone therapy. It occurs when cancer cells from the prostate spread through the blood or lymph system to other locations, most commonly to the bones. The cancer cells at this stage still depend on male hormones (androgens) for their growth. The condition typically develops from localized prostate cancer that has progressed over time. Initially, the cancer remains responsive to treatments that lower testosterone levels in the body.

Trial ID:

2024-520156-22-00

Protocol code:

CJSB462C12201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of luxdegalutamide and abiraterone combination in adult men with metastatic hormone-sensitive prostate cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?