Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

The 50 most recent of 524 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints revised (7)v524
  2. Results first posted: Jan 13, 2020v523 Show 4 more changesShow less
    • Start date: Dec 2006 to May 8, 2007
    • Primary endpoint revised
    • Study completion date: Oct 2030
    • Secondary endpoints revised (7)
  3. Primary completion date changed from estimate of Oct 2018 to Oct 2, 2018v522
  4. Primary completion date: Jun 2018 to Oct 2018
    • Site details revised at 1 of 226 sites
    v521
  5. Site details revised at 2 of 226 sitesv520
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 750 to 788
    • Site details revised at 226 of 226 sites
    v519
  2. Lead sponsor: Cancer and Leukemia Group B to Alliance for Clinical Trials in Oncologyv518 Show 6 more changesShow less
    • Study sites: 238 to 226
    • Interventions: conventional surgery (Procedure), docetaxel (Drug), goserelin acetate (Drug), leuprolide acetate (Drug) to LHRH agonist (Drug), docetaxel (Drug), surgery (Procedure)
    • Secondary endpoints: 8 to 7
    • Study description expanded, about 106 words
    • Collaborators: 3 to 4
    • Eligibility criteria expanded, about 5 words
  3. Study sites: 240 to 238v517
  4. Study sites revised (240)v516
  5. Study sites: 239 to 240v515
  6. Re-verified, no change to tracked fieldsv514
  7. Study sites: 238 to 239v513
  8. Study sites revised (238)v512
  9. Study sites: 239 to 238v511
  10. Study sites: 238 to 239v510
  11. Study sites: 239 to 238v509
  12. Study sites: 240 to 239v508
  13. Study sites: 241 to 240v507
  14. Study sites revised (241)v506
  15. Study sites: 243 to 241v505
  16. Study sites: 242 to 243v504
  17. Study sites: 241 to 242v503
  18. Study sites: 240 to 241v502
  19. Study sites: 238 to 240v501
  20. Study sites: 237 to 238v500
  21. Study sites: 238 to 237v499
  22. Study sites: 246 to 238v498
  23. Study sites: 245 to 246v497
  24. Study sites: 246 to 245v496
  25. Study sites: 245 to 246v495
  26. Study sites revised (245)v494
  27. Study sites: 244 to 245v493
  28. Site contacts updated at 2 of 244 sitesv492
  29. Study sites revised (244)v491
  30. Study sites: 243 to 244v490
  31. Study sites: 242 to 243v489
  32. Study sites: 241 to 242v488
  33. Study sites: 240 to 241v487
  34. Study sites: 241 to 240v486
  35. Site details revised at 1 of 241 sitesv485
  36. Study sites: 242 to 241v484
  37. Primary completion date: Sep 2011 to Jun 2018
    • Study sites: 236 to 242
    v483
  38. Study sites: 237 to 236v482
  39. Study sites: 235 to 237v481
  40. Study sites: 222 to 235v480
  41. Study sites: 221 to 222v479
  42. Study sites: 222 to 221v478
  43. Study sites: 223 to 222v477
  44. Site contacts updated at 2 of 223 sitesv476
  45. Study sites: 224 to 223v475
  • 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.
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as goserelin and leuprolide, may stop the adrenal glands from making androgens. Giving docetaxel and leuprolide or goserelin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether giving docetaxel and leuprolide or goserelin before surgery is more effective than surgery alone in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel and leuprolide or goserelin to see how well they work when given before surgery compared with surgery alone in treating patients with high-risk localized prostate cancer.
Trial Details
NCT Number NCT00430183
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Eastern Cooperative Oncology Group, NCIC Clinical Trials Group, SWOG Cancer Research Network
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 788 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov