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A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

Study acronym: DESTINATION
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Apr 2027 to Sep 4, 2026 · Eligibility criteria expanded, about 21 words · Secondary endpoints: details revised at 1 of 6 entries · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Apr 2027 to Sep 4, 2026
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv6
  3. Primary completion date: Apr 2025 to Apr 2027v5
  4. Primary completion date: Apr 1, 2025 to Apr 2025 Completion date: Apr 1, 2027 to Apr 2, 2027v4 Show 1 more changeShow less
    • Completion date: Apr 1, 2027 to Apr 2, 2027
  5. Trial status: Recruiting to Active, Not Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  6. Start date changed from estimate of Mar 1, 2024 to Feb 29, 2024v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: * Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects * Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Trial Details
NCT Number NCT06284304
Lead Sponsor The Netherlands Cancer Institute
Conditions Prostate Cancer
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov