Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 11, 2026 → Oct 11, 2028
See other at-risk trials from M.D. Anderson Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 11, 2026 to Oct 11, 2028
  2. Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 1 of 5 entries
  3. 3 versions Re-verified since Apr 3, 2025, no change to tracked fieldsv11-v13
  4. Primary and study completion dates: Oct 1, 2024 to Oct 11, 2026v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary and study completion dates: Oct 1, 2023 to Oct 1, 2024v8
  2. 2 versions Re-verified since Aug 16, 2023, no change to tracked fieldsv6-v7
  3. Primary completion date: Oct 1, 2022 to Oct 1, 2023v5
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jan 29, 2021 to Oct 1, 2022
    • Study completion date: Jan 29, 2021 to Oct 1, 2023
    • Start date changed from estimate of Jun 30, 2019 to Jul 22, 2019
    • Site details revised
  6. Secondary endpoints revised (5)v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03821792
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov