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Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy

Study acronym: ADAM
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: May 31, 2027 to Nov 30, 2028v5 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 260 to 190
    • Study sites: 25 to 21
    • Eligibility criteria expanded, about 116 words
  2. Study sites: 1 to 25v4
  3. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Aug 4, 2020 to Dec 10, 2020
    • Site details revised
    v3
  4. Start date changed from estimate of Apr 1, 2020 to Aug 4, 2020v2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Mar 31, 2027 to May 31, 2027
    • Eligibility criteria expanded, about 99 words
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary objective of this trial is to determine if adjuvant apalutamide in prostate cancer patients at high risk of developing subsequent metastatic disease results in prolonged biochemically recurrence-free survival after radical prostatectomy (RPE) in comparison to standard of care (SOC).
Trial Details
NCT Number NCT04295447
Lead Sponsor Universität Münster
Collaborators: Janssen Pharmaceutica N.V., Belgium
Conditions
(from sponsor)		 Prostatic Neoplasms
Related terms Neoplasms, Prostatic Neoplasms
Enrollment 190 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov