MR-guided Tumour Boost
MRL-Boost PC
1 other identifier
interventional
40
1 country
1
Brief Summary
This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Feb 2023
Longer than P75 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedStudy Start
First participant enrolled
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
March 5, 2026
March 1, 2026
7.3 years
May 3, 2022
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost
Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75
Baseline
Secondary Outcomes (3)
Acute Toxicity
Baseline to 5-year follow-up
Late Toxicity
Baseline to 5-year follow-up
Patient-reported quality-of-life assessed by EPIC-26
Baseline to 5-year follow-up
Study Arms (1)
MR-guided Tumour Boost with SBRT
EXPERIMENTALMR-guided radiotherapy boost to MRI visible tumour
Interventions
IMRT/VMAT prostate whole gland SBRT to 30 Gy in 5 fractions. MRL focal boost of 15 Gy in 1 fraction will be delivered either before or after whole gland SBRT.
Eligibility Criteria
You may qualify if:
- 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
- years of age or older
- Ability to provide written informed consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2022
First Posted
May 6, 2022
Study Start
February 6, 2023
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
March 5, 2026
Record last verified: 2026-03