Active, not recruitingPhase II🇵🇱 PolandMale onlyEN originalProstate cancerMetastatic / advanced

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

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About the trial

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

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Zdiagnozowany rak prostaty z przerzutami w innych częściach ciała
  • •Przerzuty w narządach lub co najmniej 4 przerzuty w kościach (zarejestrowane tomografią lub badaniem kości)
  • •Bardzo niski poziom testosteronu we krwi (wynik leczenia)
  • •Ogólny stan zdrowia pozwalający na udział w badaniu
  • •Możliwe wcześniejsze leczenie radurem lub chemioterapią (jeśli skończyło się ponad rok temu)

✗ Disqualifies

  • •Wcześniejsze leczenie nowymi lekami hamującymi receptor androgenowy (enzalutamid, darolutamid, apalutamid lub abirateron) przy zaawansowanym rakzie
  • •Tylko biochemiczny powrót choroby bez potwierdzenia przerzutów w badaniach obrazowych
  • •Brak przerzutów widocznych w tomografii lub badaniu kości

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
October 9, 2026
Sex
Male only

Therapies / drugs in trial

Locations (66)

University of California San Diego - Moores Cancer Center

La Jolla, United States

Saint Johns Cancer Institute

Santa Monica, United States

Rocky Mountain Cancer Centers

Denver, United States

Yale Cancer Center

New Haven, United States

Advanced Urology Ins Daytona Beach

Daytona Beach, United States

Emory University School of Medicine-Winship Cancer Institute

Atlanta, United States

Associated Urological Specialists

Chicago Ridge, United States

Mass General Hospital

Boston, United States

Michigan Institute of Urology

West Bloomfield, United States

XCancer Omaha LLC

Omaha, United States

Perlmutter Cancer Centre

New York, United States

Associated Med Professionals of NY

Syracuse, United States

Montefiore Medical Center

The Bronx, United States

MidLantic Urology

Bala-Cynwyd, United States

Fox Chase Cancer Center

Philadelphia, United States

Carolina Urologic Research Center

Myrtle Beach, United States

Tennessee Oncology

Nashville, United States

Urology San Antonio

San Antonio, United States

Inova Schar Cancer Institute

Fairfax, United States

Virginia Oncology Associates

Norfolk, United States

Fred Hutch Cancer Research

Seattle, United States

Novartis Investigative Site

Adelaide, Australia

Novartis Investigative Site

Clayton, Australia

Novartis Investigative Site

Fortaleza, Brazil

Novartis Investigative Site

Porto Alegre, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Vancouver, Canada

Novartis Investigative Site

Halifax, Canada

Novartis Investigative Site

Montreal, Canada

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Olomouc, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Nice, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Quint-Fonsegrives, France

Novartis Investigative Site

Suresnes, France

Novartis Investigative Site

Düsseldorf, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Lübeck, Germany

Novartis Investigative Site

Nürtingen, Germany

Novartis Investigative Site

Asti, Italy

Novartis Investigative Site

Padova, Italy

Novartis Investigative Site

Trento, Italy

Novartis Investigative Site

Orbassano, Italy

Novartis Investigative Site

Verona, Italy

Novartis Investigative Site

Zwolle, Netherlands

Novartis Investigative Site

Dordrecht, Netherlands

Novartis Investigative Site

Hoofddorp, Netherlands

Novartis Investigative Site

Schiedam, Netherlands

Novartis Investigative Site

Kielce, Poland

Novartis Investigative Site

Oświęcim, Poland

Novartis Investigative Site

Skorzewo, Poland

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Singapore, Singapore

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Santander, Spain

Novartis Investigative Site

Badajoz, Spain

Novartis Investigative Site

Lugo, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Córdoba, Spain

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Tainan, Taiwan

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.

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