Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastat… (NCT03821792) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer
United States60 participantsStarted 2019-07-22
Plain-language summary
This phase II trial studies how well abiraterone acetate, prednisone, and apalutamide work in treating patients with hormone-naive prostate cancer that has spread to other places in the body. Androgen can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate and apalutamide may lessen the amount of androgen made by the body.
Who can participate
Age range18 Years
SexMALE
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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) \>= 45 mL/min
* Serum potassium \>= 3.5 mEg/L
* Serum magnesium \>= 1.6 mg/dL
* Serum bilirubin \< 1.5 x institutional upper limit of normal (IULN) (except for patients with known Gilbert's disease if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible)
* Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 2.5 x IULN for patients without liver metastases. (Note: In subjects with Gilbert…