Small Renal Masses (SRM)SBRT vs RFANCT03811665
Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses
A study testing Radiofrequency Ablation and Stereotactive body radiation therapy in people with Small Renal Masses (SRM), run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Renal Masses (SRM)
- What is being tested?
- Radiofrequency Ablation and Stereotactive body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age and capable of providing informed consent
- Patients scheduled for treatment of their SRM using SBRT or RFA
- Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
- Patients who are willing to have a biopsy 12 months post-procedure
- Patients with renal tumor(s) ≤ 4.0 cm
Who cannot join
- Patients with large renal tumor(s)>4.0 cm
- Patients who are unable to have a general anesthetic
- Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
- Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study
- Evidence of metastatic disease
- Uncorrectable bleeding diathesis
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
About this study
Official title: A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.
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.
- Conditions
- Small Renal Masses (SRM)
- Being tested
- Radiofrequency Ablation, Stereotactive body radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationProcedure or surgery
Also called RFA
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.
Stereotactive body radiation therapyRadiation
Also called SBRT
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.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy (SBRT) | Experimental | Not described Receives: Radiation: Stereotactive body radiation therapy |
| Radiofrequency Ablation (RFA) | Active comparator | Not described Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.
Measured: 12 Months
Overall Survival
Defined as post-procedural survival.
Measured: 12 Months
Disease free survival
Defined as disease-free survival rate after a single procedure
Measured: 12 Months
Disease recurrence
Defined as disease recurrence rate after a single procedure, including positive biopsy result.
Measured: 12 Months
Secondary outcomes (9)
Tumour Size
Average percentage decrease in tumor size.
Measured: 12 Months
Renal Function -eGFR
Change in eGRF measured by mL/min/1.73m2.
Measured: 12 Months
Renal Function - Serum Creatinine
Change in serum creatinine level measured by umol/L.
Measured: 12 Months
Renal Function - Creatinine Clearance
Change in creatinine clearance measured by ml/minute.
Measured: 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.
Measured: 12 Months
Number of patients that experienced an adverse event.
Defined by any adverse event listed in the CTCAE.
Measured: 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.
Measured: 12 Months
Duration of hospital stay
Duration of length of hospital stay (if applicable)
Measured: Days
Cost analysis
Defined by total cost of procedure and any associated related adverse events post procedure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start1 Oct 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Renal Masses (SRM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Kapoor, St. Joseph's Healthcare Hamilton
- Investigators
- Anil Kapoor, MD FRCSC, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811665
- Sponsor's protocol ID
- RADSTER
- Acronym
- SBRT vs RFA
- Status last verified
- Dec 2021
- First submitted
- 13 Nov 2018
- Last updated
- 16 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40058468
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.
- ClinicalTrials.gov ID
- NCT03811665
- Acronym / sponsor ID
- SBRT vs RFA / RADSTER
- Conditions
- Small Renal Masses (SRM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy (SBRT) | Experimental | Radiation: Stereotactive body radiation therapy |
| Radiofrequency Ablation (RFA) | Active comparator | Procedure: Radiofrequency Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥18 years of age and capable of providing informed consent
- Patients scheduled for treatment of their SRM using SBRT or RFA
- Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
- Patients who are willing to have a biopsy 12 months post-procedure
- Patients with renal tumor(s) ≤ 4.0 cm
Key exclusion criteria (6 listed)
- Patients with large renal tumor(s)>4.0 cm
- Patients who are unable to have a general anesthetic
- Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment
- Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study
- Evidence of metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency AblationAlso: RFARFA 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. | Procedure or surgery | Radiofrequency Ablation (RFA) |
| Stereotactive body radiation therapyAlso: SBRTThe 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. | Radiation | Stereotactic body radiation therapy (SBRT) |
Primary outcome
Treatment failure
Time frame: 12 Months
Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast.
Overall Survival
Time frame: 12 Months
Defined as post-procedural survival.
Disease free survival
Time frame: 12 Months
Defined as disease-free survival rate after a single procedure
Disease recurrence
Time frame: 12 Months
Defined as disease recurrence rate after a single procedure, including positive biopsy result.
9 secondary outcomes
Tumour Size
Time frame: 12 Months
Renal Function -eGFR
Time frame: 12 Months
Renal Function - Serum Creatinine
Time frame: 12 Months
Renal Function - Creatinine Clearance
Time frame: 12 Months
Complication Rate
Time frame: 12 Months
Number of patients that experienced an adverse event.
Time frame: 12 Months
Change in score for quality of life
Time frame: 12 Months
Duration of hospital stay
Time frame: Days
Cost analysis
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Derived from this study: PubMed 40058468Cassim 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Kapoor, MD FRCSC principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation and Stereotactive body radiation therapy in people with Small Renal Masses (SRM), run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03811665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.