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Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Sponsor refiled this as active, not recruiting (was completed) Completion date: Oct 31, 2025 to Oct 31, 2030v34 Show 1 more changeShow less
    • Completion date: Oct 31, 2025 to Oct 31, 2030
  2. Study sites revised (313)v33 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv32
  4. Study sites revised (313)v31 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Active, Not Recruiting to Completed Primary and study completion dates changed from estimate of May 31, 2026 to Oct 31, 2025v30 Show 1 more changeShow less
    • Primary and study completion dates changed from estimate of May 31, 2026 to Oct 31, 2025
Show 28 earlier versionsHide 28 earlier versions
  1. Study sites revised (313)v29 See this version in full on ClinicalTrials.gov ↗
  2. Interventions: Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)… to Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)… Study sites revised (313)v28 Show 1 more changeShow less
    • Study sites revised (313)

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 314 to 313 Interventions: Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)… to Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)…v27 Show 1 more changeShow less
    • Interventions: Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)… to Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)…
  4. Study sites revised (314)v26 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (314)v25 See this version in full on ClinicalTrials.gov ↗
  6. Enrollment target: 175 to 612 Start date: Jan 16, 2017 to Apr 5, 2017 · Primary completion date: May 2026 to May 31, 2026 · Completion date: May 2031 to May 31, 2026 · 5 morev24 Show 8 more changesShow less
    • Start date: Jan 16, 2017 to Apr 5, 2017
    • Primary completion date: May 2026 to May 31, 2026
    • Completion date: May 2031 to May 31, 2026
    • Interventions: Bicalutamide (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin Acetate (Drug), Laboratory… to Bicalutamide (Drug), Degarelix (Drug), Docetaxel (Drug), External Beam Radiation Therapy (Radiation), Flutamide (Drug), Goserelin (Drug)…
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 4 to 6
    • Study description expanded, about 22 words
    • Study sites revised (314)

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites revised (314)v23 See this version in full on ClinicalTrials.gov ↗
  8. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 612 to confirmed 175 · Site details revised at 314 of 314 sitesv22 Show 2 more changesShow less
    • Enrollment target: estimated 612 to confirmed 175
    • Site details revised at 314 of 314 sites
  9. Study sites: 312 to 314v21
  10. Study sites revised (312)v20 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 308 to 312v19
  12. Study sites: 307 to 308v18
  13. Study sites: 300 to 307v17
  14. Study sites: 296 to 300v16
  15. Study sites: 293 to 296v15
  16. Site details revised at 6 of 293 sitesv14
  17. Study sites: 288 to 293v13
  18. Study sites: 283 to 288v12
  19. Study sites: 281 to 283 Eligibility criteria expanded, about 26 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 26 words

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 273 to 281v10
  21. Study sites: 271 to 273v9
  22. Study sites: 266 to 271v8
  23. Study sites: 251 to 266v7
  24. Study sites: 241 to 251v6
  25. Study sites: 229 to 241v5
  26. Study sites: 204 to 229v4
  27. Study sites: 186 to 204v3
  28. Study sites: 1 to 186 Completion date: May 2031v2 Show 1 more changeShow less
    • Completion date: May 2031
  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 randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.
Trial Details
NCT Number NCT03070886
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
Enrollment 612 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov