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Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 468 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 1 of 170 sitesv468
  2. Trial status: Active, Not Recruiting to Completed Completion date: Dec 22, 2022 · Secondary endpoints: 12 to 14v467 Show all 3 changesShow less
    • Completion date: Dec 22, 2022
    • Secondary endpoints: 12 to 14

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv466
  4. Results first posted: Oct 16, 2019 Primary endpoint revised · Interventions: iodine I 125 (Radiation), palladium Pd 103 (Radiation), radiation therapy (Radiation) to Brachytherapy (100/110) (Radiation), Brachytherapy (125/145) (Radiation), External Beam Radiation Therapy (Radiation) · Secondary endpoints: 10 to 12 · 1 morev465 Show all 5 changesShow less
    • Primary endpoint revised
    • Interventions: iodine I 125 (Radiation), palladium Pd 103 (Radiation), radiation therapy (Radiation) to Brachytherapy (100/110) (Radiation), Brachytherapy (125/145) (Radiation), External Beam Radiation Therapy (Radiation)
    • Secondary endpoints: 10 to 12
    • Study description expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date changed from estimate of Jan 2017 to May 2017 Site details revised at 1 of 170 sitesv464 Show all 2 changesShow less
    • Site details revised at 1 of 170 sites
Show 45 earlier versionsHide 45 earlier versions
  1. Re-verified, no change to tracked fieldsv463
  2. Collaborators: 1 to 2v462 Show moreShow less

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  3. Enrollment target: estimated 586 to confirmed 588 Secondary endpoints revised (10)v461 Show all 2 changesShow less
    • Secondary endpoints revised (10)

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  4. Primary completion date: Apr 2011 to Jan 2017 Trial status: Recruiting to Active, Not Recruiting · Study sites: 202 to 170v460 Show all 3 changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 202 to 170
  5. Study sites: 201 to 202v459
  6. Site contacts updated at 1 of 201 sitesv458
  7. Study sites revised (201)v457 Show moreShow less

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  8. Study sites: 200 to 201v456
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  12. Site contacts updated at 1 of 195 sitesv452
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  26. Site contacts updated at 13 of 197 sitesv438
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  28. Study sites: 197 to 198v436
  29. Re-verified, no change to tracked fieldsv435
  30. Study sites: 195 to 197v434
  31. Study sites revised (195)v433 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 205 to 195v432
  33. Study sites revised (205)v431 Show moreShow less

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  34. Study sites: 204 to 205v430
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  36. Re-verified, no change to tracked fieldsv428
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  43. Re-verified, no change to tracked fieldsv421
  44. Study sites: 204 to 205v420
  45. Study sites: 203 to 204v419
  • 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.
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.
Trial Details
NCT Number NCT00063882
Lead Sponsor Radiation Therapy Oncology Group
Collaborators: National Cancer Institute (NCI), NRG Oncology
Conditions Prostate Cancer
Enrollment 588 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov