Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa)
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)
Time on treatment
Time frame: Up to 6 months
Secondary Endpoints
Progression free survival (PFS)
Incidence of adverse events
Efficacy assessed
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * At least 2 of the 3 following high-risk prognostic factors: * Gleason score of \>= 8 * Presence of 3 or more lesions on bone scan * Presence of measurable visceral (excluding lymph node disease) metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Hemoglobin \>= 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to enrollment * Platelet count \>= 100,000/uL independent of transfusion and/or growth factors within 3 months prior to enrollment * Serum albumin \>= 3.0 g/dL * Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Calculated creatinine clearance (Cockcroft-Gault equation…
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