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Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    • Site details revised at 50 of 672 sites
  2. 2 versions Re-verified since Jun 16, 2026, no change to tracked fieldsv23-v24
  3. Study completion pushed from Apr 1, 2026 to Apr 1, 2028v22
  4. 3 versions Re-verified since Jan 23, 2026, no change to tracked fieldsv19-v21
  5. Results first posted: Jan 8, 2026v18 Show 5 more changesShow less
    • Primary completion date changed from estimate of Mar 31, 2026 to Jan 8, 2024
    • Interventions: Abiraterone Acetate (Drug), Antiandrogen Therapy (Drug), Cabazitaxel (Drug), Laboratory Biomarker Analysis (Other), Orchiectomy… to Abiraterone Acetate (Drug), Androgen deprivation therapy (Drug), Cabazitaxel (Drug), Prednisone (Drug)
    • Eligibility criteria expanded, about 69 words
    • Secondary endpoints: 6 to 5
    • Primary endpoint revised
Show 16 earlier versionsHide 16 earlier versions
  1. 2 versions Re-verified since Oct 28, 2025, no change to tracked fieldsv16-v17
  2. Primary completion date: Sep 30, 2025 to Mar 31, 2026v15
  3. Primary completion date: Mar 31, 2025 to Sep 30, 2025v14
  4. Primary completion date: Dec 31, 2024 to Mar 31, 2025v13
  5. Primary completion date: Jun 30, 2024 to Dec 31, 2024v12
  6. Start date: Feb 8, 2018 to Apr 26, 2018v11
  7. Primary completion date: Sep 1, 2023 to Jun 30, 2024v10 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 210 to confirmed 223
    • Study completion date: Apr 1, 2025 to Apr 1, 2026
    • Site details revised at 672 of 672 sites
  8. Primary completion date: Apr 1, 2023 to Sep 1, 2023v9
  9. Re-verified, no change to tracked fieldsv8
  10. Primary completion date: Apr 1, 2021 to Apr 1, 2023v7
  11. Primary completion date: Apr 1, 2020 to Apr 1, 2021
    • Study sites: 356 to 672
    v6
  12. Study title revisedv5
  13. Study sites: 1 to 356
    • Secondary endpoints reordered
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 3 words
    v4
  14. Study title shortened, about 3 wordsv3
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 9, 2018 to Feb 8, 2018
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 randomized phase II trial studies how well abiraterone acetate and antiandrogen therapy, with or without cabazitaxel and prednisone, work in treating patients with castration-resistant prostate cancer previously treated with docetaxel that has spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Hormone therapy using abiraterone acetate and antiandrogen therapy may fight prostate cancer by lowering and/or blocking the use of androgens by the tumor cells. Drugs used in chemotherapy, such as cabazitaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abiraterone acetate and antiandrogen therapy with or without cabazitaxel and prednisone may help kill more tumor cells.
Trial Details
NCT Number NCT03419234
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma in the Soft Tissue, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Adenocarcinoma AJCC v7
Related terms Prostatic Neoplasms
Enrollment 223 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov