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EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T

Study acronym: VIOLET
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Aug 3, 2025 → Sep 2028
See other at-risk trials from Peter MacCallum Cancer Centre, Australia

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 3, 2025 to Sep 2028 Show 7 more changesShow less
    • Enrollment increased: 42 → 66 participants
    • Study completion pushed from Dec 2026 to Dec 2028
    • Interventions: [ 161 Tb]Tb PSMA I&T (Drug) to [ 161 Tb]Tb PSMA I&T (Drug)
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 6 of 9 entries
    • Study description shortened, about 6 words
    • Publications: details revised at 2 of 2 entries
  2. Trial status: Active, Not Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Aug 3, 2024 to Aug 3, 2025
    • Enrollment target: 30 to 42
    • Study description revised
    • Site details revised
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 36 to confirmed 30
    • Site details revised
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Aug 2024 to Aug 3, 2024
    • Start date changed from estimate of Sep 2022 to Sep 29, 2022
    v3
  5. Start date: Aug 2022 to Sep 2022v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).
Trial Details
NCT Number NCT05521412
Lead Sponsor Peter MacCallum Cancer Centre, Australia
Conditions
(from sponsor)		 Prostate Cancer, Metastatic Castration-resistant Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov