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The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in the treatment of SRMs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiation therapy (SBRT) | Experimental |
| |
| Radiofrequency Ablation (RFA) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency Ablation | Procedure | RFA probe will create an ablation zone of a 1.0 cm diameter beyond the maximum CT-measured tumor diameter. The generator will modulate power up to 150 W in reach average ablative temperature of 105oC. Tumors will be treated for two cycles of 8 minutes duration each upon reaching target temperatures. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure | Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast. | 12 Months |
| Overall Survival | Defined as post-procedural survival. | 12 Months |
| Disease free survival | Defined as disease-free survival rate after a single procedure | 12 Months |
| Disease recurrence | Defined as disease recurrence rate after a single procedure, including positive biopsy result. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour Size | Average percentage decrease in tumor size. | 12 Months |
| Renal Function -eGFR | Change in eGRF measured by mL/min/1.73m2. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anil Kapoor, MD FRCSC | St. Joseph's Healthcare Hamilton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster Institute of Urology - St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40058468 | Derived | Cassim R, Bansal R, Millan B, Mironov O, Ahir P, Tajzler C, Hoogenes J, Matsumoto ED, Quan K, Kapoor A, Swaminath A. A Randomized Trial of Stereotactic Body Radiation Therapy vs Radiofrequency Ablation for the Treatment of Small Renal Masses: A Feasibility Study (RADSTER). Urology. 2025 Jun;200:118-124. doi: 10.1016/j.urology.2025.02.053. Epub 2025 Mar 7. |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Stereotactive body radiation therapy | Radiation | The Gross Tumour Volume (GTV) is defined as the visible tumour seen on the planning CT simulation. No clinical target volume (CTV) for microscopic disease is necessary. The internal target volume (ITV) accounts for changes in tumour position due to respiration, and is assessed on 4DCT. The planning target volume (PTV) will be a standard 0.5 cm around the ITV. |
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| Renal Function - Serum Creatinine | Change in serum creatinine level measured by umol/L. | 12 Months |
| Renal Function - Creatinine Clearance | Change in creatinine clearance measured by ml/minute. | 12 Months |
| Complication Rate | Intra and post intervention complication rates will be documented in terms of nausea, vomiting, diarrhea, hematuria, hemorrhage (requiring or not requiring transfusion), perinephric hematoma, ureteral strictures, loss of a renal unit, urinary leak, bleeding, fever and flulike symptoms, stomach/bowel ulceration, ureteropelvic junction obstruction, and upper pole hydrocalycosis. | 12 Months |
| Number of patients that experienced an adverse event. | Defined by any adverse event listed in the CTCAE. | 12 Months |
| Change in score for quality of life | Defined by the generic EuroQol (EQ-5D) questionnaire that is a standardized measure of health. A scale of 0-100 (0 being the worse health, and 100 being the best health), is used for a patient to define their overall health and wellbeing. | 12 Months |
| Duration of hospital stay | Duration of length of hospital stay (if applicable) | Days |
| Cost analysis | Defined by total cost of procedure and any associated related adverse events post procedure. | 12 Months |