MR-guided Tumour Boost

Study Overview
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Brief Summary
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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.

Official Title
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MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: MR-guided Radiotherapy Boost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-guided Tumour Boost with SBRT<br>MR-guided radiotherapy boost to MRI visible tumour | Radiation: MR-guided Radiotherapy Boost<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity | Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Baseline to 5-year follow-up | 
| Late Toxicity | Late (more than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Baseline to 5-year follow-up | 
| Patient-reported quality-of-life assessed by EPIC-26 | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1-, 3-, and 6-months post radiation as well as years 1, 2, 3, 4, and 5) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26) | Baseline to 5-year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, SBRT, stereotactic body radiotherapy, tumour boost