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A Phase 3, Randomized, Open-Label Study of MK-5684 (004) Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment with One Nextgeneration Hormonal Agent (NHA).

Primary:
Objective: To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1, as assessed by BICR in participants with mCRPC.

Hypothesis (H1): MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in AR LBD mutation positive participants.

Hypothesis (H3): MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in AR LBD mutation negative participants.

- To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to overall survival in participants with mCRPC.

Hypothesis (H2): MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival in AR LBD mutation positive participants.

Hypothesis (H4): MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to overall survival in AR LBD mutation negative participants.

Protocol Number: 082307
Phase: Phase III
Applicable Disease Sites: Prostate
Drugs Involved: Abiraterone
Enzalutamide
MK-5684
PREDNISONE
Principal Investigator: Biren Saraiya
Scope: National
Therapies Involved: Chemotherapy multiple agents systemic
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.