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A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

Study acronym: LIBERTAS
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 30 of 41 entries · Site details revised at 4 of 93 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 30 of 41 entries
    • Site details revised at 4 of 93 sites
  2. Study sites revised (93)v43 See this version in full on ClinicalTrials.gov ↗
  3. 2 versions Re-verified since Jul 2, 2026, no change to tracked fieldsv41-v42
  4. Study sites revised (93)v40 See this version in full on ClinicalTrials.gov ↗
  5. 3 versions Re-verified since Jan 15, 2026, no change to tracked fieldsv37-v39
Show 35 earlier versionsHide 35 earlier versions
  1. Study sites: 92 to 93v36
  2. Re-verified, no change to tracked fieldsv35
  3. Primary completion date: Aug 31, 2026 to Oct 12, 2026 Completion date: Aug 31, 2026 to Oct 12, 2028v34 Show 1 more changeShow less
    • Completion date: Aug 31, 2026 to Oct 12, 2028
  4. 2 versions Re-verified since Aug 15, 2025, no change to tracked fieldsv32-v33
  5. Trial status: Recruiting to Active, Not Recruiting Study sites: 91 to 92 · Primary completion date: Jan 7, 2027 to Aug 31, 2026 · Completion date: Mar 21, 2027 to Aug 31, 2026 · 2 morev31 Show 5 more changesShow less
    • Study sites: 91 to 92
    • Primary completion date: Jan 7, 2027 to Aug 31, 2026
    • Completion date: Mar 21, 2027 to Aug 31, 2026
    • Secondary endpoints: details revised at 41 of 41 entries
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Site details revised at 70 of 91 sitesv30
  7. Completion date: Apr 14, 2027 to Mar 21, 2027v29
  8. 2 versions Re-verified since Mar 27, 2025, no change to tracked fieldsv27-v28
  9. Study sites: 90 to 91v26
  10. Re-verified, no change to tracked fieldsv25
  11. Study sites revised (90)v24 See this version in full on ClinicalTrials.gov ↗
  12. Re-verified, no change to tracked fieldsv23
  13. Site details revised at 1 of 90 sitesv22
  14. Completion date: Jan 7, 2027 to Apr 14, 2027v21
  15. Re-verified, no change to tracked fieldsv20
  16. Enrollment target: 333 to 420 Eligibility criteria expanded, about 96 words · Study sites revised (90)v19 Show 2 more changesShow less
    • Eligibility criteria expanded, about 96 words
    • Study sites revised (90)

    See this version in full on ClinicalTrials.gov ↗

  17. Primary and study completion dates: May 31, 2027 to Jan 7, 2027 Study sites revised (90)v18 Show 1 more changeShow less
    • Study sites revised (90)

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 89 to 90v17
  19. Study sites revised (89)v16 See this version in full on ClinicalTrials.gov ↗
  20. Study sites: 85 to 89v15
  21. Study sites: 79 to 85v14
  22. Study sites: 64 to 79v13
  23. Study sites: 54 to 64v12
  24. Study sites: 48 to 54v11
  25. Study sites: 39 to 48v10
  26. Study sites: 24 to 39v9
  27. Study sites: 1 to 24v8
  28. Re-verified, no change to tracked fieldsv7
  29. Trial status: Not Yet Recruiting to Recruiting Study sites: 6 to 1v6 Show 1 more changeShow less
    • Study sites: 6 to 1
  30. 3 versions Re-verified since Jun 27, 2023, no change to tracked fieldsv3-v5
  31. Eligibility criteria expanded, about 31 words Secondary endpoints: details revised at 1 of 41 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 41 entries

    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.
The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
Trial Details
NCT Number NCT05884398
Lead Sponsor Janssen Research & Development, LLC
Conditions Metastatic Castrate-sensitive Prostate Cancer
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov