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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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)
Step 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
Step 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 trial?

10 criteria

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 trial?

14 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Albert Schweitzer Ziekenhuis
Verified
Dordrecht, The Netherlands
Istituto Oncologico Veneto
Responsive
Padua, Italy
Sint Franciscus Vlietland Groep Stichting
Responsive
Rotterdam, The Netherlands

Trial locations

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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.

What is already known about the treatment

Abiraterone
An oral medication used in the treatment of metastatic prostate cancer that works by blocking the production of androgens (male hormones) throughout the body, including in the prostate, adrenal glands, and tumor tissue. This medication belongs to the class of drugs known as CYP17 inhibitors and is typically administered once daily in tablet form along with prednisone. Abiraterone is particularly effective in treating hormone-sensitive prostate cancer by suppressing testosterone production, which helps slow or stop cancer growth.
JSB462 (Luxdegalutamide)
An investigational drug being studied in clinical trials for the treatment of metastatic hormone-sensitive prostate cancer, administered orally once daily in doses of 100mg or 300mg. This medication is being evaluated in combination with abiraterone as a potential treatment option for adult male patients with metastatic prostate cancer. As an androgen receptor pathway inhibitor (ARPI), it works by blocking the effects of male hormones on prostate cancer cells.

Investigated diseases

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.