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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06991556
Registration number
NCT06991556
Ethics application status
Date submitted
8/05/2025
Date registered
28/05/2025
Date last updated
10/09/2025
Titles & IDs
Public title
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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Scientific 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)
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Secondary ID [1]
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2024-520156-22
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Secondary ID [2]
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CJSB462C12201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Hormone-sensitive Prostate Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JSB462
Treatment: Drugs - Abiraterone
Treatment: Drugs - Enzalutamide
Experimental: Arm 1 - JSB462 100 mg QD + abiraterone 1000 mg QD
Experimental: Arm 2 - JSB462 300 mg QD + abiraterone 1000 mg QD
Active comparator: Arm 3 - abiraterone 1000 mg QD or enzalutamide 160 mg QD
Treatment: Drugs: JSB462
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.
Treatment: Drugs: Abiraterone
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.
Treatment: Drugs: Enzalutamide
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prostate Specific Antigen 90 (PSA90) Rate
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Assessment method [1]
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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.
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Timepoint [1]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Primary outcome [2]
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Incidence rate of adverse events (AEs)
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Assessment method [2]
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The analysis of adverse events will include categorization by type, frequency, and severity, as graded by the NCI CTCAE version 5.0.
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Timepoint [2]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Primary outcome [3]
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Number of participants with dose adjustments
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Assessment method [3]
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The number of participants with dose adjustments (reductions, interruption, or permanent discontinuation) will be summarized by treatment arm.
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Timepoint [3]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Primary outcome [4]
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Duration of exposure to study treatment
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Assessment method [4]
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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.
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Timepoint [4]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Secondary outcome [1]
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Radiographic Progression Free Survival (rPFS)
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Assessment method [1]
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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
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Timepoint [1]
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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
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall Survival (OS) is defined as the time between randomization and death due to any cause
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Timepoint [2]
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From date of randomization until date of death from any cause, assessed up to approximately 83 months
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Secondary outcome [3]
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Incidence rate of adverse events (AEs)
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Assessment method [3]
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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.
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Timepoint [3]
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From date of randomization till 30 days safety fup, assessed up to approximately 83 months
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Secondary outcome [4]
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Overall Response Rate (ORR)
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Assessment method [4]
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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
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Timepoint [4]
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From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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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
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Timepoint [5]
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From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months
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Secondary outcome [6]
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Duration of Response (DOR)
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Assessment method [6]
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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
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Timepoint [6]
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From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to approximately 83 months
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Secondary outcome [7]
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Time to Response (TTR)
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Assessment method [7]
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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
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Timepoint [7]
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From date of randomization until date of first documented Complete Response (CR) or Partial Response (PR), assessed up to approximately 83 months
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Secondary outcome [8]
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Time to soft tissue progression (TTSTP)
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Assessment method [8]
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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
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Timepoint [8]
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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
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Secondary outcome [9]
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Prostate Specific Antigen 30 (PSA30) Rate
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Assessment method [9]
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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
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Timepoint [9]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Secondary outcome [10]
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Prostate Specific Antigen 50 (PSA50) Rate
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Assessment method [10]
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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
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Timepoint [10]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Secondary outcome [11]
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Prostate Specific Antigen 0 (PSA0) Rate
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Assessment method [11]
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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
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Timepoint [11]
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From date of randomization till 30 days safety fup, assessed up to approximately 75 months
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Secondary outcome [12]
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Duration of biochemical response (DBR)
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Assessment method [12]
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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
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Timepoint [12]
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From date of date of first PSA50 response until date of PSA progression or death from any cause, assessed up to approximately 83 months
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Secondary outcome [13]
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Time to first symptomatic skeletal event (TTSSE)
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Assessment method [13]
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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
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Timepoint [13]
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From date of randomization till EOT or death, whichever happens first, assessed up to approximately 83 months
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Secondary outcome [14]
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Plasma concentrations of JSB462 and plasma concentrations of its metabolite ARV-767
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Assessment method [14]
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JSB462 pharmacokinetic (PK) samples will be obtained and evaluated in all participants at all dose levels in JSB462 treatment arms.
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Timepoint [14]
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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.
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Secondary outcome [15]
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Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [15]
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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.
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Timepoint [15]
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From randomization up till 30 day safety Follow-up, assessed up to approximately 83 months
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Eligibility
Key inclusion criteria
Key
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/07/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/09/2035
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Novartis Investigative Site - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Nebraska
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Country [2]
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United States of America
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State/province [2]
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South Carolina
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Singapore
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State/province [5]
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Singapore
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Country [6]
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South Korea
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State/province [6]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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 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
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Trial website
https://clinicaltrials.gov/study/NCT06991556
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06991556
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