Status:
RECRUITING
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Hormone-sensitive Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 7 2035
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06991556
Start Date
July 7 2025
End Date
November 7 2035
Last Update
January 7 2026
Active Locations (47)
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1
University of California San Diego - Moores Cancer Center
La Jolla, California, United States, 92093-0658
2
Saint Johns Cancer Institute
Santa Monica, California, United States, 90404
3
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
4
Emory University School of Medicine-Winship Cancer Institute
Atlanta, Georgia, United States, 30322