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New combo therapy aims to slow prostate cancer spread

NCT ID NCT06991556

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 10 times

Summary

This study tests a new drug, JSB462, combined with standard therapy (abiraterone) in 150 men whose prostate cancer has spread but still responds to hormone treatment. The goal is to see if the combination lowers PSA levels more effectively and delays cancer growth. Participants will receive either the new combo or another standard treatment, and researchers will monitor safety and side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

168 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Sep 2035

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer

Contacts and locations

Locations

  • Advanced Urology Ins Daytona Beach

    Daytona Beach, Florida, 32114, United States

  • Associated Med Professionals of NY

    Syracuse, New York, 13210, United States

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutch Cancer Research

    Seattle, Washington, 98109, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Mass General Hospital

    Boston, Massachusetts, 02114, United States

  • Michigan Institute of Urology

    West Bloomfield, Michigan, 48322, United States

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Fortaleza, Ceará, 60140-025, Brazil

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01221-020, Brazil

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    Beijing, Chaoyang, 100021, China

  • Novartis Investigative Site

    Beijing, 100034, China

  • Novartis Investigative Site

    Brno, 656 53, Czechia

  • Novartis Investigative Site

    Olomouc, 779 00, Czechia

  • Novartis Investigative Site

    Prague, 150 06, Czechia

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189, France

  • Novartis Investigative Site

    Marseille, 13273, France

  • Novartis Investigative Site

    Quint-Fonsegrives, 31130, France

  • Novartis Investigative Site

    Suresnes, 92150, France

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Novartis Investigative Site

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Nürtingen, 72622, Germany

  • Novartis Investigative Site

    Asti, AT, 14100, Italy

  • Novartis Investigative Site

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    Trento, TN, 38122, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Zwolle, Overijssel, 8025 AB, Netherlands

  • Novartis Investigative Site

    Dordrecht, South Holland, 3318 AT, Netherlands

  • Novartis Investigative Site

    Hoofddorp, 2134 TM, Netherlands

  • Novartis Investigative Site

    Schiedam, 3118 JH, Netherlands

  • Novartis Investigative Site

    Kielce, 25-640, Poland

  • Novartis Investigative Site

    Oświęcim, 32-600, Poland

  • Novartis Investigative Site

    Skorzewo, 60-185, Poland

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Singapore, 308433, Singapore

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Santander, Cantabria, 39008, Spain

  • Novartis Investigative Site

    Badajoz, Extremadura, 06080, Spain

  • Novartis Investigative Site

    Lugo, Galicia, 27003, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Perlmutter Cancer Centre

    New York, New York, 10016, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Saint Johns Cancer Institute

    Santa Monica, California, 90404, United States

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • University of California San Diego - Moores Cancer Center

    La Jolla, California, 92093-0658, United States

  • Urology San Antonio

    San Antonio, Texas, 78229, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • XCancer Omaha LLC

    Omaha, Nebraska, 68130, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06520, United States

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