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An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

Study acronym: PSMAndARPI
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 27 words Study description revised Show 1 more changeShow less
    • Study description revised
  2. Primary endpoint(s) modified Primary and study completion moved earlier from Apr 9, 2029 to Oct 15, 2026 · Secondary endpoints shortened, about 57 words · Study description expanded, about 20 words · 1 morev20 Show 4 more changesShow less
    • Primary and study completion moved earlier from Apr 9, 2029 to Oct 15, 2026
    • Secondary endpoints shortened, about 57 words
    • Study description expanded, about 20 words
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. Trial sites reduced: 13 → 5 locationsv19
  4. Study sites: 14 to 13v18
  5. Enrollment target: estimated 420 to confirmed 7 Trial status: Recruiting to Active, Not Recruiting · Study sites: 15 to 14v17 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 14
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 14 to 15v16
  2. Study sites: 9 to 14v15
  3. Study sites: 8 to 9v14
  4. Site contacts updated at 2 of 8 sitesv13
  5. Study sites: 5 to 8v12
  6. Study sites: 4 to 5v11
  7. Site contacts updated at 3 of 4 sitesv10
  8. Study sites: 2 to 4 Start date changed from estimate of Aug 29, 2025 to Sep 11, 2025v9 Show 1 more changeShow less
    • Start date changed from estimate of Aug 29, 2025 to Sep 11, 2025
  9. Study sites: 1 to 2v8
  10. Site contact updatedv7
  11. Site contact updated Study title expanded, about 1 wordv6 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v5 Show 1 more changeShow less
    • Study sites: 0 to 1
  13. Primary completion date: Apr 1, 2027 to Apr 9, 2029 Completion date: Apr 29, 2027 to Apr 9, 2029 · Start date: Aug 22, 2025 to Aug 29, 2025v4 Show 2 more changesShow less
    • Completion date: Apr 29, 2027 to Apr 9, 2029
    • Start date: Aug 22, 2025 to Aug 29, 2025
  14. Re-verified, no change to tracked fieldsv3
  15. Study title shortened, about 12 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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 study is to assess safety of combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI and AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the metastic castrate resistant prostate cancer (mCRPC) setting.
Trial Details
NCT Number NCT06894511
Lead Sponsor Novartis Pharmaceuticals
Conditions Metastatic Castration Resistant Prostate Cancer (mCRPC)
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov