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Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 0 → 1 primary endpoints
See other at-risk trials from NRG Oncology

Record History

  1. Completion pushed from Oct 27, 2026 to Mar 10, 2030 Eligibility criteria shortened, about 26 words · Secondary endpoints: details revised at 9 of 13 entries · Site details revised at 37 of 360 sites · 2 more Show 5 more changesShow less
    • Eligibility criteria shortened, about 26 words
    • Secondary endpoints: details revised at 9 of 13 entries
    • Site details revised at 37 of 360 sites
    • Publications: details revised at 2 of 2 entries
    • Study description shortened, about 5 words
  2. Re-verified, no change to tracked fieldsv35
  3. Primary endpoint(s) modified Primary endpoint(s) modified · Results first posted: Jul 10, 2026 · Completion pushed from Mar 1, 2026 to Oct 27, 2026 · 2 morev34 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Results first posted: Jul 10, 2026
    • Completion pushed from Mar 1, 2026 to Oct 27, 2026
    • Enrollment target: 296 to 298
    • Site details revised at 1 of 360 sites
  4. Enrollment target: 324 to 296 Completion date: Mar 10, 2031 to Oct 27, 2026 · Study description expanded, about 97 wordsv33 Show 2 more changesShow less
    • Completion date: Mar 10, 2031 to Oct 27, 2026
    • Study description expanded, about 97 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoint revised Completion date: Mar 1, 2026 to Mar 10, 2031 · Secondary endpoints: 14 to 13 · Study description shortened, about 97 wordsv32 Show 3 more changesShow less
    • Completion date: Mar 1, 2026 to Mar 10, 2031
    • Secondary endpoints: 14 to 13
    • Study description shortened, about 97 words

    See this version in full on ClinicalTrials.gov ↗

Show 30 earlier versionsHide 30 earlier versions
  1. Study sites revised (360)v31 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 362 to 360v30
  3. Primary completion date changed from estimate of Mar 1, 2026 to Mar 10, 2025v29
  4. Study sites: 363 to 362v28
  5. Study sites revised (363)v27 See this version in full on ClinicalTrials.gov ↗
  6. Study sites revised (363)v26 See this version in full on ClinicalTrials.gov ↗
  7. Primary and study completion dates: Mar 1, 2025 to Mar 1, 2026v25
  8. Start date: Apr 27, 2018 to Jun 20, 2018 Enrollment target: 311 to 324 · Primary completion date: Dec 31, 2025 to Mar 1, 2025 · Completion date: Oct 31, 2028 to Mar 1, 2025 · 7 morev24 Show 10 more changesShow less
    • Enrollment target: 311 to 324
    • Primary completion date: Dec 31, 2025 to Mar 1, 2025
    • Completion date: Oct 31, 2028 to Mar 1, 2025
    • Interventions: Apalutamide (Drug), External Beam Radiation Therapy (Radiation), Placebo (Other) to Apalutamide (Drug), External Beam Radiation Therapy (Radiation), Placebo Administration (Other)
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints revised (14)
    • Primary endpoint revised
    • Study description expanded, about 14 words
    • Site details revised at 1 of 363 sites
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  9. Primary completion date: Dec 31, 2024 to Dec 31, 2025 Study sites revised (363)v23 Show 1 more changeShow less
    • Study sites revised (363)

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites revised (363)v22 See this version in full on ClinicalTrials.gov ↗
  11. Primary completion date: Feb 16, 2024 to Dec 31, 2024v21
  12. Study sites revised (363)v20 See this version in full on ClinicalTrials.gov ↗
  13. Eligibility criteria expanded, about 22 wordsv19 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (363)v18 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 364 to 363v17
  16. Enrollment target: estimated 324 to confirmed 311v16
  17. Study sites revised (364)v15 See this version in full on ClinicalTrials.gov ↗
  18. Trial status: Recruiting to Active, Not Recruiting Study sites: 328 to 364v14 Show 1 more changeShow less
    • Study sites: 328 to 364
  19. Study sites: 300 to 328v13
  20. Study title shortened, about 4 wordsv12 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 291 to 300v11
  22. Study sites: 217 to 291v10
  23. Secondary endpoints revised (14) Study description revisedv9 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  24. Study sites: 174 to 217v8
  25. Study sites: 115 to 174v7
  26. Study sites: 40 to 115v6
  27. Study sites: 1 to 40v5
  28. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  29. Start date: Apr 13, 2018 to Apr 27, 2018v3
  30. Start date: Feb 16, 2018 to Apr 13, 2018v2
  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.
NRG Oncology
67 trials monitored
See 5 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.
Trial Details
NCT Number NCT03371719
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Prostate Carcinoma, Stage III Prostate Adenocarcinoma AJCC v7, Stage IV Prostate Adenocarcinoma AJCC v7
Enrollment 298 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov