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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MR-guided Tumour Boost with SBRT | Experimental | MR-guided radiotherapy boost to MRI visible tumour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MR-guided Radiotherapy Boost | Radiation | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network, Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |