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Long-Term Safety of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Prostate Cancer

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites revised (54)v10 See this version in full on ClinicalTrials.gov ↗
  2. Primary endpoint revised Eligibility criteria shortened, about 28 words · Secondary endpoints: 1 to 2 · Study sites revised (54)v9 Show 3 more changesShow less
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints: 1 to 2
    • Study sites revised (54)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 2 to 54v8
  4. Re-verified, no change to tracked fieldsv7
  5. Study sites: 1 to 2v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Jul 6, 2033 to Jul 20, 2033 Completion date: Jul 7, 2033 to Jul 21, 2033 · Start date: Jul 31, 2023 to Aug 14, 2023v4 Show 2 more changesShow less
    • Completion date: Jul 7, 2033 to Jul 21, 2033
    • Start date: Jul 31, 2023 to Aug 14, 2023
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Novartis
555 trials monitored
See 31 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
The purpose of this post-marketing study is to further characterize the long-term outcome of known or potential risks of lutetium (177Lu) vipivotide tetraxetan also known as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereinafter referred to as AAA617. The study also seeks to further characterize (as possible) any other AAA617 causally related serious adverse event(s) in the long-term in adults with prostate cancer who received at least one dose of AAA617 from interventional, Phase I-IV Novartis sponsored clinical trials.
Trial Details
NCT Number NCT05803941
Lead Sponsor Novartis Pharmaceuticals
Conditions Prostate Cancer
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov