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Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Study acronym: ENZAMET
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Sep 2023 to Dec 31, 2026
    • Study completion date: Dec 2024 to Jun 30, 2027
    • Collaborators: 3 to 4
    v16
  2. Study completion date: Dec 2023 to Dec 2024
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study sites revised (82)
    • Collaborators: 4 to 3
    v15
  3. Primary completion date: Sep 2020 to Sep 2023
    • Study completion date: Dec 2020 to Dec 2023
    v14
  4. Site details revised at 5 of 82 sitesv13
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1100 to confirmed 1125
    • Site details revised at 82 of 82 sites
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Study sites: 71 to 82v10
  3. Re-verified, no change to tracked fieldsv9
  4. Study sites: 70 to 71v8
  5. Study sites: 68 to 70v7
  6. Study sites: 65 to 68v6
  7. Study sites: 64 to 65v5
  8. Study sites: 41 to 64v4
  9. Site details revised at 1 of 41 sitesv3
  10. Interventions: Enzalutamide plus LHRHA or surgical castration (Drug), NSAA plus LHRHA or surgical castration (Drug) to Enzalutamide (Drug), LHRHA or Surgical Castration (Drug), NSAA (Drug)
    • Secondary endpoints revised (5)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.
Trial Details
NCT Number NCT02446405
Lead Sponsor University of Sydney
Collaborators: Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Cancer Trials Ireland, Canadian Cancer Trials Group, Astellas Pharma Inc
Conditions
(from sponsor)		 Prostatic Neoplasms
Related terms Prostatic Neoplasms
Enrollment 1,125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov