SABR Treatments for Prostate Cancer
(iSMART Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial requires you to stop taking anticoagulation and immunosuppressive medications. If you are on these, you may need to discontinue them to participate.
What data supports the idea that SABR Treatments for Prostate Cancer is an effective treatment?
The available research shows that SABR treatments for prostate cancer are effective, especially for low- and intermediate-risk patients. Two large studies compared SABR to traditional radiation methods and found it to be a promising option. SABR is also well-tolerated and less costly, which could make it more accessible. However, for high-risk patients, more research is needed before it can be widely recommended outside of clinical trials.12345
What safety data is available for SABR treatment in prostate cancer?
SABR, also known as SBRT or UHRT, has been studied for its safety and efficacy in prostate cancer treatment. For low- and intermediate-risk patients, it has been compared to conventional radiotherapy in large randomized studies, showing it to be feasible and well-tolerated with careful planning. However, for high-risk patients, there is insufficient data to recommend its use outside clinical trials. Studies have also reviewed toxicity and quality of life, indicating that SABR is increasingly adopted due to its cost-effectiveness and potential to increase system capacity.12567
Is the treatment Stereotactic Ablative Body Radiation (SABR) promising for prostate cancer?
Yes, SABR is a promising treatment for prostate cancer, especially for low and intermediate-risk patients. It uses high precision to target cancer with fewer sessions, which can save time and money for both patients and healthcare systems. It is becoming a standard treatment in some places due to its effectiveness and efficiency.13489
What is the purpose of this trial?
Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.
Research Team
Danny Vesprini, MD
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
Men with confirmed prostate adenocarcinoma, classified as low risk (T1-T2b, grade group 1, PSA <10 ng/ml) or favorable intermediate risk. Intermediate risk is defined by only one factor: cT2c, grade group 2, PSA between 10-20 ng/ml; or Grade group 3 with PSA <20 and <cT2c where pattern 4/5 is less than 10%.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either two weekly fractions of 13.5 Gy or five every other day fractions of 8 Gy of stereotactic ablative body radiotherapy (SABR)
Follow-up
Participants are monitored for safety, effectiveness, and quality of life changes after treatment
Treatment Details
Interventions
- Stereotactic Ablative Body Radiation
Stereotactic Ablative Body Radiation is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine cancer
- Pancreatic cancer
- Kidney cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine cancer
- Pancreatic cancer
- Kidney cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine cancer
- Pancreatic cancer
- Kidney cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine cancer
- Pancreatic cancer
- Kidney cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Prostate Cure Foundation
Collaborator