MRL-Boost: MR-guided Tumour Boost
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MR-guided Tumour Boost with SBRT MR-guided radiotherapy boost to MRI visible tumour |
Radiation: MR-guided Radiotherapy Boost
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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost [Baseline]
Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75
Secondary Outcome Measures
- Acute Toxicity [Baseline to 5-year follow-up]
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
- Late Toxicity [Baseline to 5-year follow-up]
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
- Patient-reported quality-of-life assessed by EPIC-26 [Baseline to 5-year follow-up]
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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network, Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-6162