Clinical Trials List
Protocol NumberCJSB462C12201
NCT Number(ClinicalTrials.gov Identfier)NCT06991556
Active
2025-07-01 - 2029-02-12
Phase II
Recruiting2
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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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Yuh-Shyan Tsai
Co-Principal Investigator
- 詹皓程
- 姜伯璋
- 林琨哲
- 鍾秉軒
- Kuan-Yu Wu
- Wen-Pin Su
- Kwang-Yu Chang Division of Hematology & Oncology
- 謝宜珈
- Che-Yuan Hu
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Hormone-sensitive Prostate Cancer
Objectives
This Phase II trial aims to evaluate the efficacy and safety of JSB462 (also known as luxdegalutamide) 100 mg and 300 mg once daily (QD) plus abiraterone compared to androgen receptor pathway inhibitors (ARPIs, abiraterone, or enzalutamide) in mHSPC participants, and to select the recommended dosage for Phase III trials. To this end, this trial will evaluate overall efficacy, safety, tolerability, and pharmacokinetic (PK) data from randomized participants.
Test Drug
Tablets
Active Ingredient
Luxdegalutamide
Dosage Form
110
Dosage
100 mg
Endpoints
Efficacy: The PSA90 ratio is defined as the proportion of participants whose prostate-specific antigen (PSA) has decreased by ≥90% since baseline at any time point, confirmed by a second PSA measurement (at least 3 weeks apart) and whose PSA has not worsened during this period.
Safety: Adverse events (AEs) of type, frequency, and severity as determined by Common Adverse Event Evaluation Criteria (CTCAE) version 5.0, as well as changes in laboratory values, vital signs, and electrocardiogram (ECG).
Tolerability: Interruption of treatment, dose reduction, discontinuation of treatment, dose intensity, and duration of exposure to the investigational treatment (all investigational drugs).
Safety: Adverse events (AEs) of type, frequency, and severity as determined by Common Adverse Event Evaluation Criteria (CTCAE) version 5.0, as well as changes in laboratory values, vital signs, and electrocardiogram (ECG).
Tolerability: Interruption of treatment, dose reduction, discontinuation of treatment, dose intensity, and duration of exposure to the investigational treatment (all investigational drugs).
Inclution 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.
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.
Exclusion Criteria
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
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
The Estimated Number of Participants
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Taiwan
4 participants
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Global
150 participants
