Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer

StatusCompleted
PhaseEarly Phase 1
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Jul 2026 to Feb 9, 2024
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv41
  3. Study completion date: Jul 2025 to Jul 2026v40
  4. 2 versions Re-verified since Feb 6, 2025, no change to tracked fieldsv38-v39
  5. Study completion date: Dec 2024 to Jul 2025v37
Show 35 earlier versionsHide 35 earlier versions
  1. 3 versions Re-verified since Feb 12, 2024, no change to tracked fieldsv34-v36
  2. Study completion date: Dec 2023 to Dec 2024v33
  3. 3 versions Re-verified since Apr 10, 2023, no change to tracked fieldsv30-v32
  4. Study completion date: Dec 2022 to Dec 2023v29
  5. 2 versions Re-verified since Jun 21, 2022, no change to tracked fieldsv27-v28
  6. Study completion date: Dec 2021 to Dec 2022v26
  7. 2 versions Re-verified since May 21, 2021, no change to tracked fieldsv24-v25
  8. Study completion date: Dec 2020 to Dec 2021v23
  9. Phase: Not applicable to Early Phase 1v22
  10. Re-verified, no change to tracked fieldsv21
  11. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 40 to confirmed 19
    • Primary completion date changed from estimate of Jun 2020 to Aug 12, 2019
    v20
  12. Start date: Apr 8, 2015 to Apr 13, 2015v19
  13. Trial status: Recruiting to Suspended Sponsor's reason: Temporarily suspended by data monitoring
    • Site details revised
    v18
  14. Primary completion date: Dec 2019 to Jun 2020v17
  15. Site contact updatedv16
  16. 3 versions Re-verified since Nov 1, 2018, no change to tracked fieldsv13-v15
  17. Primary completion date: Dec 2018 to Dec 2019
    • Study completion date: Dec 2019 to Dec 2020
    • Site contact updated
    v12
  18. Re-verified, no change to tracked fieldsv11
  19. Enrollment target: 25 to 40v10 Show 4 more changesShow less
    • Primary completion date: Apr 2018 to Dec 2018
    • Study completion date: Apr 2018 to Dec 2019
    • Start date: Apr 2015 to Apr 8, 2015
    • Site contact updated
  20. Enrollment target: 40 to 25
    • Study description revised
    v9
  21. 2 versions Re-verified since Dec 28, 2016, no change to tracked fieldsv7-v8
  22. Study description revised
    • Site contact updated
    v6
  23. Site contact updatedv5
  24. Study completion date: Apr 2018
    • Site contact updated
    • Eligibility criteria expanded, about 4 words
    v4
  25. Site contact updatedv3
  26. Re-verified, no change to tracked fieldsv2
  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.
Abiraterone is approved in the United States by the U.S. Food and Drug Administration (FDA) to treat metastatic prostate cancer at 1000 mg daily. The purpose of this study is to find out if an on and off schedule of taking abiraterone would prolong the participant's cancer's response to this drug and maintain their functionality to perform their daily activities.
Trial Details
NCT Number NCT02415621
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Conditions
(from sponsor)		 Prostate Cancer
Related terms Neoplasm Metastasis, Prostatic Neoplasms
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov