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Metastatic Hormone-sensitive Prostate CancerPhase 2NCT06991556

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

A Phase 2 study testing JSB462, Abiraterone and Enzalutamide in people with Metastatic Hormone-sensitive Prostate Cancer, run by Novartis Pharmaceuticals at 65 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
JSB462, Abiraterone and Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
65 sitesin 15 countries
Study dates
7 Jul 2025to 4 Oct 2035
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

65 sites in 15 countries.

65 sites in 15 countries

United States21 sites

  • Emory University School of Medicine-Winship Cancer Institute

    Atlanta, Georgia, 30322

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

  • Mass General Hospital

    Boston, Massachusetts, 02114

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

  • Advanced Urology Ins Daytona Beach

    Daytona Beach, Florida, 32114

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • University of California San Diego - Moores Cancer Center

    La Jolla, California, 92093-0658

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Perlmutter Cancer Centre

    New York, New York, 10016

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • XCancer Omaha LLC

    Omaha, Nebraska, 68130

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Urology San Antonio

    San Antonio, Texas, 78229

  • Saint Johns Cancer Institute

    Santa Monica, California, 90404

  • Fred Hutch Cancer Research

    Seattle, Washington, 98109

  • Associated Med Professionals of NY

    Syracuse, New York, 13210

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Michigan Institute of Urology

    West Bloomfield, Michigan, 48322

Other trials in United States

Italy5 sites

  • Novartis Investigative Site

    Asti, AT, 14100

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Padova, PD, 35128

  • Novartis Investigative Site

    Trento, TN, 38122

  • Novartis Investigative Site

    Verona, VR, 37134

Other trials in Italy

Spain5 sites

  • Novartis Investigative Site

    Badajoz, Extremadura, 06080

  • Novartis Investigative Site

    Barcelona, 08036

  • Novartis Investigative Site

    Córdoba, 14004

  • Novartis Investigative Site

    Lugo, Galicia, 27003

  • Novartis Investigative Site

    Santander, Cantabria, 39008

Other trials in Spain

France4 sites

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189

  • Novartis Investigative Site

    Quint-Fonsegrives, 31130

  • Novartis Investigative Site

    Suresnes, 92150

Other trials in France

Germany4 sites

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Nürtingen, 72622

Other trials in Germany

Brazil3 sites

  • Novartis Investigative Site

    Fortaleza, Ceará, 60140-025

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01221-020

Other trials in Brazil

Canada3 sites

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Czechia3 sites

  • Novartis Investigative Site

    Brno, 656 53

  • Novartis Investigative Site

    Olomouc, 779 00

  • Novartis Investigative Site

    Prague, 150 06

Other trials in Czechia

Netherlands3 sites

  • Novartis Investigative Site

    Dordrecht, South Holland, 3318 AT

  • Novartis Investigative Site

    Hoofddorp, 2134 TM

  • Novartis Investigative Site

    Zwolle, Overijssel, 8025 AB

Other trials in Netherlands

Poland3 sites

  • Novartis Investigative Site

    Kielce, 25-640

  • Novartis Investigative Site

    Oświęcim, 32-600

  • Novartis Investigative Site

    Skorzewo, 60-185

Other trials in Poland

Singapore3 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169608

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

Australia2 sites

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

  • Novartis Investigative Site

    Clayton, Victoria, 3168

Other trials in Australia

China2 sites

  • Novartis Investigative Site

    Beijing, Chaoyang, 100021

  • Novartis Investigative Site

    Beijing, 100034

Other trials in China

South Korea2 sites

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

Taiwan2 sites

  • Novartis Investigative Site

    Kaohsiung City, 833

  • Novartis Investigative Site

    Tainan, 704302

Other trials in Taiwan

About this study

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)

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

Read the detailed description

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.
Being tested
JSB462, Abiraterone, Enzalutamide
Keywords
Interventional, clinical trial, open-label, JSB462, luxdegalutamide, efficacy, safety, tolerability, abiraterone, metastatic hormone-sensitive prostate cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSB462Drug

    Also called luxdegalutamide

    JSB462 is administered 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.

  • AbirateroneDrug

    Abiraterone 1000 mg is administered 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.

  • EnzalutamideDrug

    Enzalutamide 160 mg is administered 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.

Study groups in NCT06991556
Study groupRoleWhat they receive
Arm 1ExperimentalJSB462 100 mg QD + abiraterone 1000 mg QD
Receives: Drug: JSB462; Drug: Abiraterone
Arm 2ExperimentalJSB462 300 mg QD + abiraterone 1000 mg QD
Receives: Drug: JSB462; Drug: Abiraterone
Arm 3Active comparatorabiraterone 1000 mg QD or enzalutamide 160 mg QD
Receives: Drug: Abiraterone; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prostate Specific Antigen 90 (PSA90) Rate

    Prostate Specific Antigen 90 (PSA90) Rate is defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between.

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

  2. Incidence rate of adverse events (AEs)

    The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

  3. Number of participants with dose adjustments

    The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

  4. Duration of exposure to study treatment

    The duration of exposure in weeks to study treatment and for each study treatment component (JSB462, abiraterone and enzalutamide) will be summarized for each study treatment component by means of descriptive statistics using the SAS.

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

Secondary outcomes (15)

  1. Radiographic Progression Free Survival (rPFS)

    Radiographic Progression Free Survival (rPFS) is defined as the time between randomization and the first occurrence of disease progression (per PCWG3-modified RECIST 1.1 as assessed by the investigator) or death due to any cause

    Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 83 months

  2. Overall Survival (OS)

    Overall Survival (OS) is defined as the time between randomization and death due to any cause

    Measured: From date of randomization until date of death from any cause, assessed up to approximately 83 months

  3. Incidence rate of adverse events (AEs)

    The analysis of adverse events and laboratory abnormalities will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 83 months

  4. Overall Response Rate (ORR)

    Overall Response Rate (ORR) is defined as the proportion of participants achieving a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator

    Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months

  5. Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the proportion of participants achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST 1.1 as assessed by the investigator

    Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months

  6. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the time between first documented CR/PR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator

    Measured: From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months

  7. Time to Response (TTR)

    Time to response (TTR) is defined as the time from randomization to the date of first documented CR or PR per PCWG3-modified RECIST 1.1 as assessed by the investigator

    Measured: From date of randomization until date of first documented Complete Response (CR) or Partial Response (PR), assessed up to approximately 83 months

  8. Time to soft tissue progression (TTSTP)

    Time to soft tissue progression (TTSTP) is defined as the time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST 1.1 as assessed by the investigator

    Measured: From date of randomization until date of soft tissue radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 83 months

  9. Prostate Specific Antigen 30 (PSA30) Rate

    Prostate Specific Antigen 30 (PSA30) Rate is defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

  10. Prostate Specific Antigen 50 (PSA50) Rate

    Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

  11. Prostate Specific Antigen 0 (PSA0) Rate

    Prostate Specific Antigen 0 (PSA0) Rate is defined as the proportion of participants who achieve a PSA level <0.2 ng/ml at any timepoint after start of treatment, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between

    Measured: From date of randomization till 30 days safety fup, assessed up to approximately 75 months

  12. Duration of biochemical response (DBR)

    Duration of biochemical response (DBR) is defined as the time between PSA90 and/or PSA0 and PSA progression (increase ≥25% in PSA and an absolute increase of ≥2 ng/mL from NADIR) or death due to any cause

    Measured: From date of date of first PSA50 response until date of PSA progression or death from any cause, assessed up to approximately 83 months

  13. Time to first symptomatic skeletal event (TTSSE)

    Time to first symptomatic skeletal event (TTSSE) is defined as the date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first

    Measured: From date of randomization till EOT or death, whichever happens first, assessed up to approximately 83 months

  14. Plasma concentrations of JSB462 and plasma concentrations of its metabolite ARV-767

    JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels in JSB462 treatment arms.

    Measured: Day 1 of Cycles 1 and 2: Pre-dose/0h and Post-dose 4h +/- 1h. Day 1 of Cycles 3 to 8: Pre-dose/0h. End of Treatment Visit (EOT): Anytime. 1 cycle = 28 days.

  15. Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    The PRO-CTCAE is a patient-reported outcomes measurement system developed by the National Cancer Institute as a companion to the CTCAE. It includes items covering participant-reported symptomatic adverse events (AEs) from the CTCAE. Each symptomatic AE concept has up to three items evaluating frequency, severity, or interference, focused on the study population and treatment regimens.

    Participants respond on a 5-point scale for each item:

    • Frequency: Never, Rarely, Occasionally, Frequently, Almost constantly
    • Severity: None, Mild, Moderate, Severe, Very severe
    • Interference: Not at all, A little bit, Somewhat, Quite a bit, Very much

    The past 7-day recall version is used, focusing on relevant symptoms like fatigue, diarrhea, and hot flashes.

    Measured: From randomization up till 30 day safety Follow-up, assessed up to approximately 83 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2025
  2. Study start7 Jul 2025
  3. Primary completion15 Mar 2032 (estimated)
  4. Study completion4 Oct 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06991556
Sponsor's protocol ID
CJSB462C12201
Other IDs
2024-520156-22-00
Status last verified
Oct 2026
First submitted
8 May 2025
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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