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Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: May 15, 2033 to May 23, 2035
    • Study sites: 0 to 9
    • Start date changed from estimate of May 15, 2025 to May 23, 2025
    v4
  2. Primary completion date: Sep 15, 2029 to May 15, 2033v3 Show 4 more changesShow less
    • Start date: Jun 15, 2024 to May 15, 2025
    • Study completion date: Dec 15, 2030 to Jun 1, 2039
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints: 8 to 7
  3. Start date: Dec 15, 2023 to Jun 15, 2024v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study addresses the global topic of treatment optimization, i.e. achieving similar benefit while reducing the duration of treatment, hence hoping to decrease the burden of side-effects, improve quality-of life and reduce resource utilization. The primary goal of de-escalation is to investigate whether using an intermittent regime results in a similar OS to continuous treatment.
Trial Details
NCT Number NCT05974774
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Collaborators: Cancer Trials Ireland, UNICANCER, Spanish Oncology Genito-Urinary Group
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 1,600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov