Prostate CancerMICRO-SNCT07737457
MICRO-ultrasound Guided Prostate SBRT
A study testing Stereotactic Body Radiation Therapy and ExactVu in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy and ExactVu
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
London Health Sciences Centre, Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9
Lucas Mendez, MD, 519-685-8500, Lucas.Mendez@lhsc.on.ca
About this study
Official title: MICRO-ultrasound Guided Prostate SBRT (MICRO-S)
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.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy, ExactVu
- Keywords
- Intermediate risk prostate cancer, Prostate carcinoma
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Standard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days)
Stereotactic Body Radiation TherapyRadiation
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.
ExactVuDevice
microUltrasound
| Study group | Role | What they receive |
|---|---|---|
| CT-Guided, mpMRI Assisted Whole Prostate SBRT | Active comparator | Not described Receives: Radiation: Stereotactic Body Radiation Therapy |
| CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost | Experimental | Not described Receives: Radiation: Stereotactic Body Radiation Therapy; Device: ExactVu |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From enrollment to 3 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737457
- Sponsor's protocol ID
- ReDA 16985
- Acronym
- MICRO-S
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MICRO-ultrasound Guided Prostate SBRT (MICRO-S)
- ClinicalTrials.gov ID
- NCT07737457
- Acronym / sponsor ID
- MICRO-S / ReDA 16985
- Conditions
- Prostate Cancer
- Keywords
- Intermediate risk prostate cancer, Prostate carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation TherapyStandard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days) | Radiation | CT-Guided, mpMRI Assisted Whole Prostate SBRT |
| Stereotactic Body Radiation TherapyMicro-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. | Radiation | CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost |
| ExactVumicroUltrasound | Device | CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost |
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
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RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy and ExactVu in people with Prostate Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas Mendez, MD (519-685-8500, Lucas.Mendez@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.