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5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Study acronym: PROMPT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria shortened, about 90 words Site contacts updated at 1 of 4 sitesv7 Show 1 more changeShow less
    • Site contacts updated at 1 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 26 words Site details revised at 3 of 4 sitesv6 Show 1 more changeShow less
    • Site details revised at 3 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 2025 to Jun 30, 2030 Completion date: Jan 2026 to Jun 30, 2033 · Eligibility criteria shortened, about 31 words · Site contacts updated at 3 of 4 sitesv5 Show 3 more changesShow less
    • Completion date: Jan 2026 to Jun 30, 2033
    • Eligibility criteria shortened, about 31 words
    • Site contacts updated at 3 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 16 words Site details revised at 2 of 4 sitesv4 Show 1 more changeShow less
    • Site details revised at 2 of 4 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jan 2023 to Jan 2025 Site contacts updated at 1 of 4 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 4 sites
  6. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2021 to Jul 12, 2021 · Site details revised at 4 of 4 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2021 to Jul 12, 2021
    • Site details revised at 4 of 4 sites
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
Trial Details
NCT Number NCT04610372
Lead Sponsor British Columbia Cancer Agency
Conditions Oligometastatic Prostate Cancer
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov