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)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Prostate
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Age: Between 18 Year(s) - 99 Year(s)
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Gender: Male
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Other Inclusion Criteria:
In order to participate in this study the following conditions must be met:- Participant must be an adult male patients =18 years of age.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =2.
- Histological and/or cytological confirmation of adenocarcinoma of the prostate.
You may not be eligible for this study if the following are true:
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You will not be able to participate in this study if you have:
- Ongoing participation in any other interventional trial.
- Any investigational agents received within 28 days (or 5 half-lives, whichever is longer) prior to randomization.
- Participants with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan).
- 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 a second generation 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.
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