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RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)

StatusActive, Not Recruiting
PhasePhase 4
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 66 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Study sites revised (118)v66 See this version in full on ClinicalTrials.gov ↗
  2. Study sites revised (118)v65 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (118)v64 See this version in full on ClinicalTrials.gov ↗
  4. Interventions: NAH therapy (Drug), Radium-223 dichloride (Xofigo, BAY88-8223) (Drug) to ARPI therapy (Drug), Radium-223 dichloride (Xofigo, BAY88-8223) (Drug) Eligibility criteria revisedv63 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  5. Completion date: Oct 10, 2026 to Oct 12, 2026 Study sites revised (118)v62 Show 1 more changeShow less
    • Study sites revised (118)

    See this version in full on ClinicalTrials.gov ↗

Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 5 of 118 sitesv61
  2. Study title shortened, about 13 wordsv60 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (118)v59 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (118)v58 See this version in full on ClinicalTrials.gov ↗
  5. Enrollment target: estimated 696 to confirmed 654 Completion date: Oct 22, 2026 to Oct 10, 2026 · Study sites revised (118)v57 Show 2 more changesShow less
    • Completion date: Oct 22, 2026 to Oct 10, 2026
    • Study sites revised (118)

    See this version in full on ClinicalTrials.gov ↗

  6. Primary completion date: Nov 17, 2025 to Nov 21, 2025 Study sites revised (118)v56 Show 1 more changeShow less
    • Study sites revised (118)

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  7. Study sites revised (118)v55 See this version in full on ClinicalTrials.gov ↗
  8. Re-verified, no change to tracked fieldsv54
  9. Study sites revised (118)v53 See this version in full on ClinicalTrials.gov ↗
  10. Primary completion date: Aug 9, 2025 to Nov 17, 2025 Study sites revised (118)v52 Show 1 more changeShow less
    • Study sites revised (118)

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites revised (118)v51 See this version in full on ClinicalTrials.gov ↗
  12. Study sites revised (118)v50 See this version in full on ClinicalTrials.gov ↗
  13. Study sites revised (118)v49 See this version in full on ClinicalTrials.gov ↗
  14. Primary completion date: Jun 27, 2025 to Aug 9, 2025 Study sites revised (118)v48 Show 1 more changeShow less
    • Study sites revised (118)

    See this version in full on ClinicalTrials.gov ↗

  15. Primary completion date: May 1, 2025 to Jun 27, 2025 Completion date: May 1, 2026 to Oct 22, 2026 · Study sites revised (118)v47 Show 2 more changesShow less
    • Completion date: May 1, 2026 to Oct 22, 2026
    • Study sites revised (118)

    See this version in full on ClinicalTrials.gov ↗

  16. Site details revised at 1 of 118 sitesv46
  17. Re-verified, no change to tracked fieldsv45
  18. Study sites revised (118)v44 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 117 to 118v43
  20. Study sites revised (117)v42 See this version in full on ClinicalTrials.gov ↗
  21. Completion date: May 1, 2025 to May 1, 2026 Study sites revised (117)v41 Show 1 more changeShow less
    • Study sites revised (117)

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  22. Re-verified, no change to tracked fieldsv40
  23. Trial status: Recruiting to Active, Not Recruiting Study sites: 157 to 117v39 Show 1 more changeShow less
    • Study sites: 157 to 117
  24. Study sites revised (157)v38 See this version in full on ClinicalTrials.gov ↗
  25. Re-verified, no change to tracked fieldsv37
  26. Study sites revised (157)v36 See this version in full on ClinicalTrials.gov ↗
  27. Re-verified, no change to tracked fieldsv35
  28. Site details revised at 3 of 157 sitesv34
  29. Study sites revised (157)v33 See this version in full on ClinicalTrials.gov ↗
  30. Study sites revised (157)v32 See this version in full on ClinicalTrials.gov ↗
  31. Site details revised at 1 of 157 sitesv31
  32. Study sites revised (157)v30 See this version in full on ClinicalTrials.gov ↗
  33. Study sites revised (157)v29 See this version in full on ClinicalTrials.gov ↗
  34. Study sites revised (157)v28 See this version in full on ClinicalTrials.gov ↗
  35. Study sites revised (157)v27 See this version in full on ClinicalTrials.gov ↗
  36. Primary and study completion dates: Apr 25, 2024 to May 1, 2025 Site details revised at 4 of 157 sitesv26 Show 1 more changeShow less
    • Site details revised at 4 of 157 sites
  37. Study sites: 156 to 157v25
  38. Study sites: 155 to 156v24
  39. Site details revised at 4 of 155 sitesv23
  40. Study sites revised (155)v22 See this version in full on ClinicalTrials.gov ↗
  41. Study sites revised (155)v21 See this version in full on ClinicalTrials.gov ↗
  42. Study sites: 154 to 155v20
  43. Site details revised at 7 of 154 sitesv19
  44. Study sites revised (154)v18 See this version in full on ClinicalTrials.gov ↗
  45. Study sites: 152 to 154 Eligibility criteria expanded, about 31 wordsv17 Show 1 more changeShow less
    • Eligibility criteria expanded, about 31 words

    See this version in full on ClinicalTrials.gov ↗

  • 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.
Bayer
131 trials monitored
See 7 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and androgen receptor pathway inhibitor (ARPI) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of ARPI therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and ARPI therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The ARPI drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer. Participants in this study will receive either Radium-223 dichloride or a ARPI therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral ARPI therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.
Trial Details
NCT Number NCT04597125
Lead Sponsor Bayer
Conditions Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Enrollment 654 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov