MR-guided radiotherapy boost for localized prostate cancer
MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer
This study is testing a new way of using MRI-guided radiotherapy to target tumors in men with localized prostate cancer to see if it helps improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05364229 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to recruit 40 patients with localized prostate cancer who have MRI-defined lesions. Participants will receive an MR-guided radiotherapy boost targeting the visible tumor before or after whole gland radiation. The study will follow participants for up to 5 years post-treatment to assess outcomes and safety. The approach combines advanced imaging with targeted therapy to potentially improve treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older with histologically-proven localized prostate cancer and MRI-visible tumors.
Not a fit: Patients with prior pelvic radiotherapy or those with contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance tumor control and improve outcomes for patients with localized prostate cancer.
How similar studies have performed: While there is ongoing research in MR-guided therapies, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically-proven localized prostate cancer. * Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor) * Low-risk: cT1-T2a, PSA \<10, and Gleason score 6 * Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7 * High-risk limited to 1 risk factor: \>T2, PSA \>20, or Gleason score \>7 * Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/\< 1/3 total prostate volume * Planned for EBRT (+/- ADT) * ECOG 0 or 1 * 18 years of age or older * Ability to provide written informed consent to participate in the study Exclusion Criteria: * Prior radiotherapy to pelvis * Radiological evidence of regional or distant metastases at the discretion of the treating physician. * Active ulcerative colitis or Crohn's Disease, at discretion of treating physician * Ataxia Telangectasia and SLE * Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury * Severe claustrophobia
Where this trial is running
Toronto, Ontario
- University Health Network, Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Peter Chung, MD
- Email: peter.chung@uhn.ca
- Phone: 416-946-4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.