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Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer

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

Record History

  1. Primary completion pushed from Nov 21, 2026 to Dec 31, 2026
    • Study completion pushed from Nov 21, 2027 to Dec 31, 2027
    v14
  2. 2 versions Re-verified since Nov 13, 2025, no change to tracked fieldsv12-v13
  3. Primary completion date: Nov 21, 2024 to Nov 21, 2026
    • Study completion date: Nov 21, 2025 to Nov 21, 2027
    v11
  4. Primary completion date: Nov 21, 2023 to Nov 21, 2024
    • Study completion date: Nov 21, 2024 to Nov 21, 2025
    v10
  5. Primary completion date: Nov 21, 2022 to Nov 21, 2023
    • Study completion date: Nov 21, 2023 to Nov 21, 2024
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 30
    • Site details revised at 3 of 3 sites
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Study sites: 2 to 3v6
  4. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Nov 26, 2022 to Nov 21, 2022
    • Study completion date: Nov 26, 2023 to Nov 21, 2023
    • Start date changed from estimate of Nov 26, 2018 to Nov 21, 2018
    • Site details revised at 2 of 2 sites
  5. Start date: Aug 1, 2018 to Nov 26, 2018
    • Primary completion date: Aug 1, 2022 to Nov 26, 2022
    • Study completion date: Aug 1, 2023 to Nov 26, 2023
    v4
  6. Start date: May 1, 2018 to Aug 1, 2018
    • Primary completion date: May 1, 2022 to Aug 1, 2022
    • Study completion date: May 1, 2023 to Aug 1, 2023
    • Site contacts updated at 1 of 2 sites
    v3
  7. Start date: Dec 18, 2017 to May 1, 2018
    • Primary completion date: Dec 18, 2021 to May 1, 2022
    • Study completion date: Dec 18, 2022 to May 1, 2023
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 enzalutamide with or without radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Enzalutamide is an androgen receptor inhibitor that may slow down the growth of prostate cancer by blocking the action of the male hormone testosterone and other male hormones called androgens. Radiation therapy uses high energy alpha particles to kill tumor cells and shrink tumors. Enzalutamide with or without radium Ra 223 dichloride may work better in treating patients with castration-resistant prostate cancer.
Trial Details
NCT Number NCT03344211
Lead Sponsor University of Southern California
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Castration-Resistant Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov