Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature
Sponsor: M.D. Anderson Cancer Center + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression free survival (PFS)
Time frame: From enrollment until radiographic progression, death from any cause, start of other therapy or last follow-up without progression, whichever comes first assessed up to 28 months
Secondary Endpoints
Incidence of adverse events
Composite progression free survival (PFSc)
Overall survival (OS)
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * Presence of metastatic disease that can be biopsied by any methodology applicable * Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., surgical or medical castration) * Serum testosterone level =\< 50 ng/dL at the screening visit * Progressive disease defined as one or more of the following three criteria (NOTE: Patients who received an antiandrogen must demonstrate disease progression following discontinuation of antiandrogen): * PSA progression defined by a minimum of two rising PSA levels with an interval of \>= 1 weeks between each determination. The PSA value at the screening visit should be \>= 2 ng/mL * Soft tissue disease progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) * Bone disease progression defined by two or more…
Read full criteria on CT.gov →✦ Analyst Commentary
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