An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

No open prediction endpoints

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Key Facts

Eligibility Criteria

Inclusion Criteria: * Participants with confirmed prostate cancer, with evidence of castration resistance, with a rising prostate-specific antigen (PSA) while on androgen deprivation therapy (ADT), and for whom the treating physician believes additional therapy is indicated in the non-metastatic castrate-resistant prostate cancer (NM-CRPC) setting a) Willingness to continue gonadotropin releasing hormone analog (GnRHa) throughout study if the participant is medically castrated * Must sign an informed consent form (ICF) (or the participant's legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * To avoid risk of drug exposure through the ejaculate (even participants with vasectomies), participants must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed while …

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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