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Study identifier: NCT06991556 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Metastatic Hormone-sensitive Prostate Cancer  ·  Sponsor: Novartis Pharmaceuticals

PhasePhase 2
Planned participants150
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated

This description comes directly from the study's public registry record.

Talk to the study team

Novartis Pharmaceuticals  ·  1-888-669-6682  ·  novartis.email@novartis.com

Novartis Pharmaceuticals  ·  +41613241111  ·  novartis.email@novartis.com

Always discuss trial participation with your own doctor first.

Locations (67)

University of California San Diego - Moores Cancer CenterLa Jolla, California, United StatesRecruiting
Saint Johns Cancer InstituteSanta Monica, California, United StatesRecruiting
Rocky Mountain Cancer CentersDenver, Colorado, United StatesRecruiting
Yale Cancer CenterNew Haven, Connecticut, United StatesRecruiting
Advanced Urology Ins Daytona BeachDaytona Beach, Florida, United StatesRecruiting
Emory University School of Medicine-Winship Cancer InstituteAtlanta, Georgia, United StatesRecruiting
Associated Urological SpecialistsChicago Ridge, Illinois, United StatesRecruiting
American Oncology Partners PA Center for Cancer and Blood DisordersBethesda, Maryland, United StatesRecruiting
Mass General HospitalBoston, Massachusetts, United StatesRecruiting
Michigan Institute of UrologyWest Bloomfield, Michigan, United StatesRecruiting
XCancer Omaha LLCOmaha, Nebraska, United StatesRecruiting
Perlmutter Cancer CentreNew York, New York, United StatesRecruiting

+ 55 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06991556