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NCT03821792PHASE2ACTIVE_NOT_RECRUITING

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Interventions
Abiraterone Acetate, Apalutamide, Prednisone
Enrollment
60 participants
Primary completion
Oct 2026
Study completion
Oct 2026
First posted
Jan 2019
Last updated
Apr 2026

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

Read full criteria on CT.gov →

✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov