MRI Guided SBRT for Localized Prostate Cancer (NCT03778112) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MRI Guided SBRT for Localized Prostate Cancer
United States54 participantsStarted 2016-05-23
Plain-language summary
This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions.
In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered.
In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.
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:
* Biopsy proven prostate adenocarcinoma within 1 year of randomization
* NCCN Low to High Risk localized prostate cancer
* Zubrod Performance Status 0-1 within 60 days prior to registration
Exclusion Criteria:
* Prior or concurrent invasive malignancy (except non-melanoma skin cancer)
* Regional Lymph Node (N1) involvement
* Distant Metastases (M1) involvement
* History of prior pelvic irradiation (external beam radiotherapy or brachytherapy)
* Prior chemotherapy
* Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS)
* Acute bacterial or fungal infection requiring IV antibiotics
* Inability to undergo MRI
* Inability to receive fiducial markers
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
Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity