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Comparative Study of Radiotherapy Treatments to Treat High Risk Prostate Cancer Patients

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2026 → Dec 2028
See other at-risk trials from Sir Mortimer B. Davis - Jewish General Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2028v15
  2. Primary completion date: Oct 2021 to Dec 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 296 to confirmed 307
    • Study sites: 13 to 12
    v14
  3. Primary completion date: Jun 2021 to Oct 2021v13
  4. Primary completion date: Mar 2020 to Jun 2021
    • Site contacts updated at 1 of 13 sites
    v12
  5. Primary completion date: Jan 2019 to Mar 2020
    • Site details revised at 2 of 13 sites
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site contacts updated at 1 of 13 sitesv10
  2. Study sites: 12 to 13v9
  3. Site details revised at 2 of 12 sitesv8
  4. Study sites: 9 to 12
    • Study description expanded, about 454 words
    v7
  5. Study sites: 10 to 9v6
  6. Primary completion date: Jan 2016 to Jan 2019v5
  7. Re-verified, no change to tracked fieldsv4
  8. Site details revised at 3 of 10 sitesv3
  9. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 10 of 10 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In North America, the number of new cases of prostate cancer increases every year. Many efforts have been made to develop more efficient and safer curative treatments for high risk prostate cancer patients. This phase III clinical trial is designed to compare the safety of a standard pelvic external beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB) boost (direct insertion of radiation source over a period of minutes via flexible needles temporarily inserted in the prostate) to a shorter course of hypofractionated dose escalation radiotherapy (larger radiation dose per daily treatment) in patients with high risk prostate cancer. The investigators plan to recruit 296 patients across Quebec who will be randomized in either treatment plan.
Trial Details
NCT Number NCT02303327
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions
(from sponsor)		 Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 307 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov