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Not yet recruitingNCT07737457MICRO-SUpdated Jul 30, 2026

MICRO-ultrasound Guided Prostate SBRT

An interventional study of Stereotactic Body Radiation Therapy and Stereotactic Body Radiation Therapy in Prostate Cancer, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study summary

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.

Read the detailed description

Prostate cancer is one of the most common cancers in men, and many patients receive a treatment called external beam radiation therapy. This treatment usually works well, but in some men the cancer can return. Giving a higher dose of radiation to the whole prostate could lower this risk, but doing so can also cause more side effects to the bladder and bowel. Researchers have learned that cancer often comes back in specific spots inside the prostate called dominant intraprostatic lesions (DILs). If doctors can clearly see these areas, they may be able to safely give extra radiation just to those spots. A new type of imaging, called microultrasound (microUS), creates very detailed pictures of the prostate and may help doctors more accurately find these cancer areas.

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 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. By learning whether microUS can successfully guide targeted radiation, this research may help make advanced and more personalized prostate cancer treatment available to more patients.

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Conditions studied

  • Prostate Cancer

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Keywords

  • Intermediate risk prostate cancer
  • Prostate carcinoma
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 112 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed carcinoma of the prostate (biopsy results with 12 months of enrollment)
  • Intermediate risk as defined by NCCN criteria
  • Conventional imaging (bone scan and abdominal pelvic computed tomography) is mandatory for NCCN unfavourable intermediate risk prostate cancer patients with PSA > 10. Negative nodal, skeletal or visceral metastases within 16 weeks of enrollment (for patients requiring staging). Alternatively, patients with no signs of extra-prostatic disease on PSMA-PET scans are also candidates for this trial
  • ECOG performance status 0-1
  • Willing to give informed consent to participate in this clinical trial
  • Able and willing to complete QOL questionnaires Most responsive physician definition if androgen deprivation therapy will be used (only allowed for NCCN unfavourable intermediate risk prostate cancer)

Exclusion criteria

Exclusion Criteria:

  • Estimated prostate volume > 60cc (volume based on transrectal ultrasound)
  • Prior TURP
  • Prior prostate cancer treatment, including 5-alpha reductase inhibitor treatment
  • Low, high or very high-risk disease as per NCCN guidelines
  • Connective tissue disease or inflammatory bowel disease
  • Contraindication to prostate microUS
  • Men with double hip prostheses
  • Contraindication for MRI (i.e. non-compatible stent, pacemaker, prosthesis etc.)
  • Anticoagulation medication (if unsafe to discontinue for fiducial marker insertion)
  • Diagnosis of bleeding diathesis
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Active comparator
    CT-Guided, mpMRI Assisted Whole Prostate SBRT

    Radiation: Stereotactic Body Radiation Therapy

  • Experimental
    CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost

    Radiation: Stereotactic Body Radiation Therapy · Device: ExactVu

Interventions

  • RadiationStereotactic Body Radiation Therapy

    Standard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days)

  • RadiationStereotactic Body Radiation Therapy

    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.

  • DeviceExactVu

    microUltrasound

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What researchers measure

Primary outcomes

  1. Acute GU Toxicity Measured by Patient-Reported Outcomes in the Expanded Prostate Cancer Index (EPIC-26)

    To evaluate if microUS-guided DIL boost with dose de-escalation to the remaining prostate results in superior acute GU patient-reported outcomes when compared to standard prostate SBRT, as measured by the Expanded Prostate Cancer Index (EPIC-26)

    Time frame: From enrollment to 3 weeks after the end of treatment

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Study locations

1 site
  • London Health Sciences Centre, Verspeeten Family Cancer Centre
    London, Ontario N6A 5W9, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07737457
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Responsible party
Sponsor
First posted
Jul 30, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Mar 2033 (estimated)
Last update
Jul 30, 2026

Study contacts

Lucas Mendez, MD
Contact
Lucas.Mendez@lhsc.on.ca
519-685-8500

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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