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JSB462 with Abiraterone for Metastatic Hormone-Sensitive Prostate Cancer

This study is testing JSB462 (also called luxdegalutamide) in combination with abiraterone for men with metastatic hormone-sensitive prostate cancer (mHSPC). This means the cancer has spread to other parts of the body but still responds to hormone therapy. Researchers want to see how safe and effective JSB462 is when added to abiraterone, compared to abiraterone or enzalutamide alone. The study will also help determine the best dose of JSB462 to use in future studies. Success will be measured by how much prostate-specific antigen (PSA) levels drop and by tracking any side effects. You may be eligible if you are an adult male with this type of prostate cancer and meet other health criteria.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It aims to enroll 150 participants.
What's involved
You will have a screening period of up to 28 days, followed by a treatment period where you take JSB462 and abiraterone (or abiraterone or enzalutamide alone) daily by mouth. After treatment, there will be a safety follow-up for 30 days, then a long-term follow-up period.
Compensation
Not stated in the trial record.
Follow-up
After treatment ends, you will have a safety follow-up for 30 days. There will then be a long-term follow-up period that lasts until the end of the study, which could be up to approximately 75 months.

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NCT06991556

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~166 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:JSB462AbirateroneEnzalutamide

At a glance

Recruiting sites
0 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prostate Specific Antigen 90 (PSA90) Rate
Measured over From date of randomization till 30 days safety fup, assessed up to approximately 75 months
+3 more outcomes measured

Conditions

Metastatic Hormone-sensitive Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

66 sites across 47 states
New York3
Czechia3
France3
Germany3
Poland3
Singapore3
California2
Pennsylvania2

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2
Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible
High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and/or ≥4 metastatic bone lesions (with at least one lesion outside the vertebral column and/or pelvis) in imaging exams (CT/MRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization
Participants must have a castrate level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy and/or ongoing GnRH analog/antagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level \<0.2 ng/ml according to local laboratory as assessed by the investigator) is not achieved prior to randomization.

Exclusion

Prior exposure to a second generation ARPI (such as enzalutamide/darolutamide/apalutamide and/or abiraterone) for the treatment of advanced/metastatic disease is not allowed. Prior exposure to ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered \>12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization.
Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT/MRI or bone scan) are not eligible

What this trial measures

  • Prostate Specific Antigen 90 (PSA90) RateFrom date of randomization till 30 days safety fup, assessed up to approximately 75 months

    Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between.

  • Incidence rate of adverse events (AEs)From date of randomization till 30 days safety fup, assessed up to approximately 75 months

    The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.

  • Number of participants with dose adjustmentsFrom date of randomization till 30 days safety fup, assessed up to approximately 75 months

    The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.

  • Duration of exposure to study treatmentFrom date of randomization till 30 days safety fup, assessed up to approximately 75 months

    The duration of exposure in weeks to study treatment and for each study treatment component (JSB462, abiraterone and enzalutamide) will be summarized for each study treatment component by means of descriptive statistics using the SAS.