MICRO-ultrasound Guided Prostate SBRT

Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study ID
NCT07737457
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Body Radiation Therapy — RADIATION
    Standard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days)
  • Stereotactic Body Radiation Therapy — RADIATION
    Micro-boost to the dominant intraprostatic lesions (DILs) of 40 Gray, with the rest of the prostate receiving 35 Gray. If no DILs identified, whole prostate stereotactic body radiation therapy with dose of 35 Gray. Both interventions to be given in 5 fractions on alternate days.
  • ExactVu — DEVICE
    microUltrasound

Study Details

This study will test whether it is safe and effective to use stereotactic body radiation therapy (SBRT)-a short, targeted form of radiation-together with a microultrasound (microUS)-guided radiation boost to the cancerous spots inside the prostate. Researchers will compare treatment plans that use microUS to plans created using the current standard method, which relies on MRI images, to determine whether microUS can successfully guide targeted radiation.

Key Dates

First listed
Jul 30, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2033

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CT-Guided, mpMRI Assisted Whole Prostate SBRT
  • Experimental: CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost

Primary Outcome Measure

Acute GU Toxicity Measured by Patient-Reported Outcomes in the Expanded Prostate Cancer Index (EPIC-26) [ Time Frame: From enrollment to 3 weeks after the end of treatment ]

Central Contacts

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Nationwide
Prostate cancer trialsOncology trialsProstate oncology trialsMen's health trialsUrology trials

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