This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

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  1. Trial sites expanded: 307 → 319 locations
  2. Trial sites reduced: 337 → 307 locations
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 4 of 18 entries
  3. Trial sites reduced: 341 → 337 locationsv27
  4. Study sites revised (341)v26
  5. Study sites revised (341)v25
  6. Study sites: 340 to 341
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: 17 to 18
    v24
  7. Trial sites expanded: 332 → 340 locationsv23
  8. Study sites: 331 to 332v22
  9. Study sites: 329 to 331v21
  10. Trial sites expanded: 305 → 329 locationsv20
  11. Trial sites expanded: 302 → 305 locationsv19
  12. Study sites: 300 to 302v18
  13. Trial sites expanded: 295 → 300 locationsv17
  14. Trial sites expanded: 253 → 295 locationsv16
  15. Trial sites expanded: 188 → 253 locations
    • Eligibility criteria expanded, about 29 words
    v15
  16. Study sites: 138 to 188v14
  17. Study sites: 133 to 138v13
  18. Study sites: 108 to 133v12
  19. Study sites: 99 to 108v11
  20. Study sites: 78 to 99v10
  21. Study sites: 62 to 78v9
  22. Study sites: 45 to 62v8
  23. Study sites: 38 to 45v7
  24. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 25 to 38
    • Start date changed from estimate of Aug 25, 2025 to Sep 28, 2025
    v6
  25. Study sites: 15 to 25v5
  26. Study sites: 14 to 15v4
  27. Study sites: 10 to 14v3
  28. Study sites: 9 to 10v2
  29. Study First Submitted
  • 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.
Pfizer
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This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Trial Details
NCT Number NCT07028853
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate
Related terms Prostatic Neoplasms
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov