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ODM-201 vs Androgen Deprivation Therapy in Hormone naïve Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv7
  2. Primary completion date changed from estimate of Dec 2023 to Jan 13, 2023
    • Study completion date: May 2024 to Dec 2036
    v6
  3. Primary completion date: Dec 2022 to Dec 2023v5
  4. Primary completion date: Dec 2020 to Dec 2022v4 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 250 to confirmed 61
    • Study sites: 6 to 12
    • Study completion date: May 2022 to May 2024
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 2020 to Dec 2020
    • Start date: Mar 2017 to Dec 1, 2017
    • Study sites: 0 to 6
    • Study completion date: Jul 2021 to May 2022
  6. Primary completion date: Feb 2020 to Mar 2020
    • Study completion date: Jun 2021 to Jul 2021
    • Start date: Feb 2017 to Mar 2017
    • Collaborators expanded, about 1 word
    v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is an open label non-comparative controlled randomized phase II study. The experimental arm is the group receiving ODM-201. The group receiving androgen-deprivation therapy (ADT) is included as an internal control. The primary trial objective is to demonstrate that ODM-201 produces prostate-specific antigen (PSA) response rates at 24 weeks (defined as ≥80% reduction compared to baseline) that are in the range of those achieved with 24 weeks of ADT. In total, this 1:1 randomized study will therefore require randomization of at least 250 patients, 125 to each arm.
Trial Details
NCT Number NCT02972060
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Bayer
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov