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Radiation Therapy

SABR Treatments for Prostate Cancer (iSMART Trial)

N/A

Recruiting

Led By Danny Vesprini, MD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low risk - T1-T2b, grade group 1, AND PSA < 10 ng/ml

Histologically confirmed prostate adenocarcinoma (centrally reviewed)

Must not have

Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned

Large prostate (>90cm3) on imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare a new shorter treatment for prostate cancer using ultra-hypofractionated radiotherapy (UHRT) with the standard treatment. The new treatment involves only 2 sessions over

Who is the study for?

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%.

What is being tested?

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.

What are the potential side effects?

Stereotactic Ablative Body Radiation can cause side effects such as fatigue, skin reactions in treated areas, urinary issues like increased frequency or discomfort during urination, bowel changes including diarrhea or rectal bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is early stage, low grade, and my PSA is under 10.

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My prostate cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving or will receive hormone therapy for my cancer.

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My prostate is larger than 90cm3 according to scans.

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I am not taking any immunosuppressive medications.

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I have inflammatory bowel disease.

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I have had radiation therapy to my pelvic area before.

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I have a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prostate Cancer Patient's Quality of Life Function will be measured to determine change in Quality of life function from baseline to 5 years beyond treatment.

Secondary study objectives

Prostate

Health Utilities Outcome

Proportion of patients with 4 year PSA value of <0.4 ng/ml

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