144 Participants Needed

SABR Treatments for Prostate Cancer

(iSMART Trial)

DV
Overseen ByDanny Vesprini, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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 | Radiation Oncology

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

My prostate cancer is considered favorable risk with limited intermediate risk factors.
My prostate cancer is early stage, low grade, and my PSA is under 10.
My prostate cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

I am receiving or will receive hormone therapy for my cancer.
My prostate is larger than 90cm3 according to scans.
I am not taking any immunosuppressive medications.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

2-5 weeks
2-5 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and quality of life changes after treatment

5 years
Visits at week 1, 4, 13; month 6; and every 6 months for 5 years

Treatment Details

Interventions

  • Stereotactic Ablative Body Radiation
Trial Overview The trial compares two different schedules of delivering radiation for prostate cancer treatment. One uses the standard five sessions of SABR while the experimental approach condenses this into just two treatments a week apart to see if it's equally effective.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
Two weekly fractions of 13.5 Gy
Group II: Arm 2Active Control1 Intervention
Five every other day fractions of 8 Gy

Stereotactic Ablative Body Radiation is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Stereotactic Body Radiation Therapy (SBRT) for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Spine cancer
  • Pancreatic cancer
  • Kidney cancer
🇪🇺
Approved in European Union as Stereotactic Ablative Radiotherapy (SABR) for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Spine cancer
  • Pancreatic cancer
  • Kidney cancer
🇨🇦
Approved in Canada as Stereotactic Body Radiation Therapy (SBRT) for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Spine cancer
  • Pancreatic cancer
  • Kidney cancer
🇯🇵
Approved in Japan as Stereotactic Ablative Radiotherapy (SABR) for:
  • 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

Trials
693
Recruited
1,569,000+

Prostate Cure Foundation

Collaborator

Trials
2
Recruited
220+

Findings from Research

Stereotactic ablative radiotherapy (SABR) has been shown to be feasible and well tolerated for low- and intermediate-risk prostate cancer patients, with promising results from large randomized studies comparing it to conventional treatments.
While SABR shows potential benefits and cost-effectiveness, there is currently insufficient data to recommend its use for high-risk prostate cancer patients outside of clinical trials.
Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer.Loblaw, A.[2021]
A systematic review of studies on stereotactic body radiation therapy (SBRT) for prostate cancer found that most patients experienced mild to moderate side effects, with severe toxicity occurring in less than 3% of cases, indicating that SBRT is generally well tolerated.
The review identified important dosimetric factors that influence toxicity, such as recommended dose constraints for the bladder, urethra, and rectum, which can help optimize treatment safety and effectiveness.
Prostate Stereotactic Body Radiation Therapy: An Overview of Toxicity and Dose Response.Wang, K., Mavroidis, P., Royce, TJ., et al.[2022]
A single session of stereotactic ablative body radiotherapy (SABR) for oligometastatic prostate cancer was found to be feasible and safe, with only one significant adverse event (a vertebral fracture) reported among 33 patients over a 2-year follow-up period.
The treatment resulted in high local progression-free survival rates of 97% at 1 year and 93% at 2 years, with nearly half of the patients (48%) avoiding the need for androgen deprivation therapy at the 2-year mark, indicating effective disease control and maintained quality of life.
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial.Siva, S., Bressel, M., Murphy, DG., et al.[2022]

References

Stereotactic Ablative Body Radiotherapy for Intermediate- or High-Risk Prostate Cancer. [2021]
Prostate Stereotactic Body Radiation Therapy: An Overview of Toxicity and Dose Response. [2022]
Stereotactic Abative Body Radiotherapy (SABR) for Oligometastatic Prostate Cancer: A Prospective Clinical Trial. [2022]
Prostate stereotactic body radiotherapy—first UK experience. [2022]
Treatment outcomes of postoperative ultra-hypofractionated stereotactic body radiotherapy in prostate cancer. [2023]
Acute side effects after definitive stereotactic body radiation therapy (SBRT) for patients with clinically localized or locally advanced prostate cancer: a single institution prospective study. [2022]
Stereotactic body radiotherapy versus conventional/moderate fractionated radiation therapy with androgen deprivation therapy for unfavorable risk prostate cancer. [2021]
Evolution of hypofractionated accelerated radiotherapy for prostate cancer - the sunnybrook experience. [2022]
Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security