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Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Study acronym: PSMAcTION
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 81 → 93 locations Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 3 of 14 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Study description revised
  2. Study sites: 79 to 81v21
  3. Trial sites expanded: 72 → 79 locationsv20
  4. Trial sites expanded: 61 → 72 locationsv19
  5. Trial sites expanded: 54 → 61 locationsv18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites: 52 to 54v17
  2. Study sites: 49 to 52v16
  3. Site contacts updated at 1 of 49 sitesv15
  4. Enrollment target: 432 to 443 Study sites: 32 to 49v14 Show 1 more changeShow less
    • Study sites: 32 to 49
  5. Study sites: 28 to 32v13
  6. Study sites: 25 to 28v12
  7. Study sites: 23 to 25v11
  8. Study sites: 18 to 23 Primary completion date: Mar 20, 2028 to Jun 27, 2028 · Completion date: Apr 11, 2033 to Jul 19, 2033v10 Show 2 more changesShow less
    • Primary completion date: Mar 20, 2028 to Jun 27, 2028
    • Completion date: Apr 11, 2033 to Jul 19, 2033
  9. Study sites: 17 to 18v9
  10. Study sites: 16 to 17v8
  11. Study sites: 11 to 16v7
  12. Study sites: 7 to 11v6
  13. Study sites: 5 to 7 Primary completion date: May 12, 2028 to Mar 20, 2028 · Completion date: Jun 3, 2033 to Apr 11, 2033v5 Show 2 more changesShow less
    • Primary completion date: May 12, 2028 to Mar 20, 2028
    • Completion date: Jun 3, 2033 to Apr 11, 2033
  14. Study sites: 1 to 5 Primary completion date: May 9, 2028 to May 12, 2028 · Completion date: May 31, 2033 to Jun 3, 2033 · Secondary endpoints: 15 to 14v4 Show 3 more changesShow less
    • Primary completion date: May 9, 2028 to May 12, 2028
    • Completion date: May 31, 2033 to Jun 3, 2033
    • Secondary endpoints: 15 to 14

    See this version in full on ClinicalTrials.gov ↗

  15. Start date changed from estimate of Apr 2, 2025 to Feb 27, 2025v3
  16. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment
Trial Details
NCT Number NCT06780670
Lead Sponsor Novartis Pharmaceuticals
Conditions Prostate Cancer
Enrollment 443 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov