Clinical Trial

Dose Escalation For INtraprostatic LEsions

Study acronym: DEFINE
Recruiting Phase 2
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Summary
External beam radiotherapy combined with androgen deprivation therapy is a standard treatment option for localized prostate cancer. The current standard involves delivering radiotherapy uniformly throughout the prostate gland in daily fractions, five days per week, for approximately four weeks. In this study, radiotherapy will be delivered using an ultra-hypofractionated approach in three larger fractions on alternating days over one week Multiparametric magnetic resonance imaging will be used to guide focal dose escalation to parts of the gland harboring tumor, which could potentially reduce the risk of cancer recurrence compared to standard dose of radiotherapy. The aim of this study is to confirm that this approach can be delivered safely, that is, with rates of urinary and bowel side effects at 1 year of follow-up that are not significantly greater than the current standard.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-05-01.
Status change: Not Yet Recruiting → Recruiting 2024-01-02
Trial Details
NCT Number NCT05851547
Lead Sponsor Ottawa Hospital Research Institute
Collaborators: Knight Therapeutics (USA) Inc
Conditions Prostatic Neoplasms
Enrollment 54 participants
Start Date 2023-11-23
Primary Completion 2027-06 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2024-01-05