MICRO-ultrasound Guided Prostate SBRT

NCT07737457 | Not Yet Recruiting DMC

• 1 other identifier: ReDA 16985
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Intermediate risk prostate cancer; Prostate carcinoma

Outcome Measures

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)

  From enrollment to 3 weeks after the end of treatment

Study Arms (2)

CT-Guided, mpMRI Assisted Whole Prostate SBRT

ACTIVE COMPARATOR

Radiation: Stereotactic Body Radiation Therapy

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

EXPERIMENTAL

Radiation: Stereotactic Body Radiation Therapy; Device: ExactVu

Interventions

Stereotactic Body Radiation Therapy RADIATION

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

CT-Guided, mpMRI Assisted Whole Prostate SBRT

ExactVu DEVICE

microUltrasound

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre, Verspeeten Family Cancer Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Lucas Mendez, MD

CONTACT

519-685-8500; Lucas.Mendez@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2033
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)