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Study of JSB462 and lutetium (177Lu) vipivotide tetraxetan combination for adult men with PSMA-positive metastatic castration resistant prostate cancer

Verified siteRegistered drugNo placebo
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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 patients with metastatic castration resistant prostate cancer (mCRPC) that is PSMA-positive. The research evaluates a combination treatment using two medications: luxdegalutamide (also known as JSB462) and lutetium vipivotide tetraxetan. Luxdegalutamide is taken as a tablet by mouth, while lutetium vipivotide tetraxetan is given through an intravenous injection.

The purpose of this research is to determine the most effective dose of luxdegalutamide when used together with lutetium vipivotide tetraxetan, and to compare this combination treatment to using lutetium vipivotide tetraxetan alone. Before starting the treatment, patients will undergo imaging tests including a special type of scan called gallium gozetotide PET/CT to confirm if they are suitable for the study.

During the study, patients will be randomly assigned to receive either the combination of both medications or lutetium vipivotide tetraxetan by itself. The treatment period may continue for up to 36 months. Throughout the study, doctors will monitor how well the treatment is working and check for any side effects. They will also perform regular blood tests to measure PSA (prostate-specific antigen) levels, which help track the progress of the treatment.

The research process

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

  1. Step 1

    Initial screening

    A PET/CT scan will be performed to confirm if your cancer is suitable for the treatment (PSMA-positive).

    Your medical history will be reviewed to confirm eligibility, including previous treatments and current health status.

    Basic health checks will be performed, including assessment of your ability to perform daily activities (ECOG Performance Status).

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either:

    - Luxdegalutamide tablets (100mg or 300mg daily) plus intravenous lutetium treatment

    - Intravenous lutetium treatment alone

  3. Step 3

    Treatment administration

    If assigned to the combination group, you will take luxdegalutamide tablets orally once daily

    All participants will receive lutetium treatment through intravenous infusion

    Regular blood tests will be performed to monitor PSA levels (a protein that may indicate prostate cancer activity)

    Imaging scans will be conducted to monitor your response to treatment

  4. Step 4

    Monitoring and follow-up

    Regular health assessments will track any side effects

    Blood samples will be taken to measure drug levels in your body

    Imaging scans will be performed to check tumor response

    You will be asked to report any symptoms or changes in your condition

    The study will continue until December 2028

Who can join the trial?

7 criteria

  • Must be an adult male with confirmed prostate cancer of type adenocarcinoma (a type of cancer that starts in gland cells)
  • Must have a physical fitness score (ECOG Performance Status) of 2 or less, meaning you can perform most daily activities with minimal assistance
  • Must have at least 1 cancer spread (metastatic lesion) in bones or organs, confirmed by CT scan, MRI, or bone scan within 28 days before starting treatment
  • Must have a positive gallium PET/CT scan (a special type of imaging test that shows where cancer cells are in the body)
  • Must have previously received at least one newer generation hormone therapy (ARPI) for advanced prostate cancer
  • Can have had up to 2 previous chemotherapy treatments with taxane medications (drugs used to treat cancer)
  • If eligible for PARPi (targeted therapy drugs) or immune checkpoint inhibitors (drugs that help immune system fight cancer), must have already received these treatments

Who cannot join the trial?

14 criteria

  • History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
  • Presence of active brain metastases (spread of cancer to the brain)
  • Known hypersensitivity (allergic reaction) to the study medications or their components
  • Severe heart conditions, including:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Heart attack within the past 6 months
    • Severe liver problems or abnormal liver function tests
    • Significant kidney disease requiring dialysis
    • Active, uncontrolled infections
    • Participation in another clinical trial within 30 days before starting this study
    • Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study
    • Unable to swallow oral medications
    • Major surgery within 4 weeks before starting the study
    • Mental conditions that could affect the ability to provide informed consent
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Investigated drugs

  • JSB462

    is an investigational medication being studied in combination with another treatment for prostate cancer. It is being tested at different doses to determine which dose works best for future studies.

  • Lutetium (177Lu) vipivotide tetraxetan

    is a radioactive medication used to treat certain types of prostate cancer. It works by targeting specific proteins found on prostate cancer cells (called PSMA) and delivering radiation directly to these cancer cells. The medication is given through an intravenous infusion.

  • AAA617

    appears to be another code name for lutetium (177Lu) vipivotide tetraxetan used in this clinical trial. It is the same radioactive treatment described above that targets prostate cancer cells.

What is already known about the treatment

  • JSB462

    An investigational medication being studied in clinical trials for metastatic castration-resistant prostate cancer (mCRPC). It is administered orally once daily (QD) at doses of either 100 mg or 300 mg and is being tested in combination with lutetium-177 vipivotide tetraxetan therapy. The medication is currently in Phase II clinical trials to evaluate its efficacy, safety, and optimal dosing for future Phase III studies in treating PSMA-positive prostate cancer.

  • Lutetium (177Lu) vipivotide tetraxetan

    A radioactive therapeutic agent that specifically targets prostate-specific membrane antigen (PSMA) in metastatic prostate cancer cells. It is administered intravenously and combines a radioactive isotope (lutetium-177) with a targeting molecule that binds to PSMA on cancer cells, delivering targeted radiation therapy. This medication is being studied in combination with JSB462 to potentially enhance treatment outcomes in patients with metastatic castration-resistant prostate cancer.

Investigated diseases

Metastatic castration resistant prostate cancer (mCRPC) - A form of advanced prostate cancer that continues to progress despite medical or surgical treatments that lower testosterone. In this condition, cancer cells have spread beyond the prostate to other parts of the body (metastasized), commonly to bones, lymph nodes, or other organs. The cancer continues to grow even when testosterone levels in the body are reduced to very low levels. This stage of prostate cancer typically develops gradually, with cancer cells becoming resistant to hormone therapy over time. The disease is characterized by rising prostate-specific antigen (PSA) levels and/or visible growth of tumors on imaging scans.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520155-24-00Protocol codeCJSB462B12201Estimated enrolment87 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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