University Health Network, Toronto
06/02/2023
01/06/2030
MEN
40
18
No
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.
MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer
- 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
- 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
| PARTICIPANT GROUP 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. |
| Measures | Measure Description | MEASURE 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 |
| MEASURES | MEASURE DESCRIPTION | MEASURE 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 |