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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute GU Toxicity Measured by Patient-Reported Outcomes in the Expanded Prostate Cancer Index (EPIC-26)
Timeframe: From enrollment to 3 weeks after the end of treatment
Trial details
NCT IDNCT07737457
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's