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

NCT06991556 · Novartis
In plain English

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Official title
A Phase II, Randomized, Open-label, Multi-center Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
About this study
The study for each participant consists of a Screening period (28 days), a treatment period, a post-treatment safety follow-up (30 days) followed by a long-term follow-up period. During the treatment period: * JSB462 is administered from randomization, orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. * Abiraterone 1000 mg or enzalutamide 160 mg are administered from randomization, orally, daily, and continuously until disease progression per PCWG3-modified RECIST 1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision. During the post-treatment follow up period: * Safety follow-Up: After discontinuation of study treatment, all participants will be followed for at least 1 safety follow-up visit (30 days \[+/- 7 days\] after treatment discontinuation). Subsequent lines of therapy may be administered according to investigator's discretion after treatment discontinuation. * Long-term follow-up: Starts after the Safety follow-up period and lasts until the end of study. Safety, efficacy and survival information may be collected from participants during this period.
Eligibility criteria
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-07-07
Estimated completion: 2035-10-19
Last updated: 2026-04-16
Interventions
Drug: JSB462Drug: AbirateroneDrug: Enzalutamide
Primary outcomes
  • Prostate Specific Antigen 90 (PSA90) Rate (From date of randomization till 30 days safety fup, assessed up to approximately 75 months)
  • Incidence rate of adverse events (AEs) (From date of randomization till 30 days safety fup, assessed up to approximately 75 months)
  • Number of participants with dose adjustments (From date of randomization till 30 days safety fup, assessed up to approximately 75 months)
Sponsor
Novartis Pharmaceuticals · industry
Contacts & investigators
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · 1-888-669-6682
ContactNovartis Pharmaceuticals · contact · novartis.email@novartis.com · +41613241111
InvestigatorNovartis Pharmaceuticals · study_director, Novartis Pharmaceuticals
All locations (63)
University of California San Diego - Moores Cancer CenterRecruiting
La Jolla, California, United States
Saint Johns Cancer InstituteRecruiting
Santa Monica, California, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
Yale Cancer CenterRecruiting
New Haven, Connecticut, United States
Advanced Urology Ins Daytona BeachRecruiting
Daytona Beach, Florida, United States
Emory University School of Medicine-Winship Cancer InstituteRecruiting
Atlanta, Georgia, United States
American Oncology Partners PA Center for Cancer and Blood DisordersRecruiting
Bethesda, Maryland, United States
Mass General HospitalRecruiting
Boston, Massachusetts, United States
Michigan Institute of UrologyRecruiting
West Bloomfield, Michigan, United States
XCancer Omaha LLCRecruiting
Omaha, Nebraska, United States
Perlmutter Cancer CentreRecruiting
New York, New York, United States
Associated Med Professionals of NYRecruiting
Syracuse, New York, United States
MidLantic UrologyRecruiting
Bala-Cynwyd, Pennsylvania, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
Urology San AntonioRecruiting
San Antonio, Texas, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Fred Hutch Cancer ResearchRecruiting
Seattle, Washington, United States
Novartis Investigative SiteRecruiting
Adelaide, South Australia, Australia
Novartis Investigative SiteRecruiting
Clayton, Victoria, Australia
Novartis Investigative SiteRecruiting
São Paulo, São Paulo, Brazil
Novartis Investigative SiteRecruiting
Vancouver, British Columbia, Canada
Novartis Investigative SiteRecruiting
Halifax, Nova Scotia, Canada
Novartis Investigative SiteRecruiting
Montreal, Quebec, Canada
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Beijing, Chaoyang, China
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Beijing, China
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Brno, Czechia
Novartis Investigative SiteRecruiting
Olomouc, Czechia
Novartis Investigative SiteRecruiting
Prague, Czechia
Novartis Investigative SiteRecruiting
Nice, Alpes Maritimes, France
Novartis Investigative SiteRecruiting
Marseille, France
Novartis Investigative SiteRecruiting
Quint-Fonsegrives, France
Novartis Investigative SiteRecruiting
Suresnes, France
Novartis Investigative SiteRecruiting
Hamburg, Germany
Novartis Investigative SiteRecruiting
Lübeck, Germany
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Nürtingen, Germany
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Asti, AT, Italy
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Padova, PD, Italy
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Trento, TN, Italy
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Orbassano, TO, Italy
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Verona, VR, Italy
Novartis Investigative SiteRecruiting
Zwolle, Overijssel, Netherlands
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Dordrecht, South Holland, Netherlands
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Hoofddorp, Netherlands
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Schiedam, Netherlands
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Kielce, Poland
Novartis Investigative SiteRecruiting
Olsztyn, Poland
Novartis Investigative SiteRecruiting
Oświęcim, Poland
Novartis Investigative SiteRecruiting
Skorzewo, Poland
Novartis Investigative SiteRecruiting
Singapore, Singapore
Novartis Investigative SiteRecruiting
Singapore, Singapore
Novartis Investigative SiteRecruiting
Singapore, Singapore
Novartis Investigative SiteRecruiting
Seoul, South Korea
Novartis Investigative SiteRecruiting
Seoul, South Korea
Novartis Investigative SiteRecruiting
Santander, Cantabria, Spain
Novartis Investigative SiteRecruiting
Badajoz, Extremadura, Spain
Novartis Investigative SiteRecruiting
Lugo, Galicia, Spain
Novartis Investigative SiteRecruiting
Pamplona, Navarre, Spain
Novartis Investigative SiteRecruiting
Barcelona, Spain
Novartis Investigative SiteRecruiting
Córdoba, Spain
Novartis Investigative SiteRecruiting
Kaohsiung City, Taiwan
Novartis Investigative SiteRecruiting
Tainan, Taiwan
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) · TrialPath