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

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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 Other inclusion/exclusion criteria may apply.

Where this trial is running

• University of California San Diego - Moores Cancer Center, La Jolla, California, United States
• Saint Johns Cancer Institute, Santa Monica, California, United States
• Rocky Mountain Cancer Centers, Denver, Colorado, United States
• Yale Cancer Center, New Haven, Connecticut, United States
• Advanced Urology Ins Daytona Beach, Daytona Beach, Florida, United States
• Emory University School of Medicine-Winship Cancer Institute, Atlanta, Georgia, United States
• Associated Urological Specialists, Chicago Ridge, Illinois, United States
• American Oncology Partners PA Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
• Mass General Hospital, Boston, Massachusetts, United States
• Michigan Institute of Urology, West Bloomfield, Michigan, United States
• XCancer Omaha LLC, Omaha, Nebraska, United States
• Perlmutter Cancer Centre, New York, New York, United States

+ 55 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06991556.