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Radiation Therapy
Arm 1 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
iSMART Trial 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%.Check my eligibility
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.See study design
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.
iSMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is early stage, low grade, and my PSA is under 10.
Select...
My prostate cancer diagnosis was confirmed through a biopsy.
iSMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Prostate
Health Utilities Outcome
Proportion of patients with 4 year PSA value of <0.4 ng/ml
+2 moreSide effects data
From 2021 Phase 2 trial • 20 Patients • NCT0181898655%
Fatigue
30%
Nausea
15%
Urinary urgency
15%
Vomiting
15%
Chills
15%
Dyspnea
10%
White blood cells decreased
10%
Anxiety
10%
Diarrhea
10%
Fever
10%
Lymphocyte Count Decrease
5%
Rectal Pain
5%
Non-Cardiac Chest Pain
5%
Pruritis
5%
Productive cough
5%
Urinary Retention
5%
Urinary Tract Obstruction
5%
Thrombolic Event
5%
Photosensitivity
5%
Rectal Urgency
5%
Alkaline Phosphatase Increased
5%
Anemia
5%
Back pain
5%
Constipation
5%
Cough
5%
Dehydration
5%
Extrapyramidal disorder
5%
Generalized muscle weakness
5%
Headaches
5%
Hot Flashes
5%
Hypocalcemia
5%
Hypophosphatemia
5%
Lethargy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm One
iSMART Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Ablative Body Radiation
2013
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,163 Total Patients Enrolled
34 Trials studying Prostate Cancer
12,494 Patients Enrolled for Prostate Cancer
Prostate Cure FoundationUNKNOWN
1 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Prostate Cancer
75 Patients Enrolled for Prostate Cancer
Danny Vesprini, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are potential participants currently able to apply for enrollment in this clinical trial?
"Indeed, the details on clinicaltrials.gov affirm that this study is actively seeking volunteers. Originally uploaded on March 1st, 2024, and updated most recently on April 16th, 2024, the trial aims to enroll a total of 144 participants at one designated site."
Answered by AI
What is the current number of individuals undergoing treatment within this clinical trial?
"Yes, information available on clinicaltrials.gov indicates that this particular clinical trial is currently seeking eligible individuals. The trial was first posted on March 1st, 2024 and last updated on April 16th, 2024. It aims to recruit a total of 144 participants at one designated site."
Answered by AI
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