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:

  • Conditions:
    Prostate
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male
  • Other Inclusion Criteria:
    In order to participate in this study the following conditions must be met:
    1. Participant must be an adult male patients =18 years of age.
    2. An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) =2.
    3. Histological and/or cytological confirmation of adenocarcinoma of the prostate.

You may not be eligible for this study if the following are true:

  • You will not be able to participate in this study if you have:
    1. Ongoing participation in any other interventional trial.
    2. Any investigational agents received within 28 days (or 5 half-lives, whichever is longer) prior to randomization.
    3. Participants with biochemical recurrence only or those without evidence of metastatic disease by radiographical imaging (CT/MRI or bone scan).
    4. 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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