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Radiation Therapy
SABR for Prostate Cancer (2SMART Trial)
N/A
Waitlist Available
Led By Andrew Loblaw, MD, FRCPC
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
Histologically confirmed prostate adenocarcinoma (centrally reviewed)
Men over 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 year
Awards & highlights
2SMART Trial Summary
This trial will study the prostate-specific quality of life of patients undergoing a two-fraction MRI-guided stereotactic ablative body radiation protocol.
Who is the study for?
This trial is for men over 18 with confirmed prostate adenocarcinoma, at an early stage (T1-2c), Gleason Sum ≤7, and PSA ≤20 ng/mL. It's not for those on immunosuppressants, with hip replacements, MRI contraindications, long-term hormone therapy (>6 months), bleeding disorders, inflammatory bowel disease, large prostates (>90cm3), or previous pelvic radiotherapy.Check my eligibility
What is being tested?
The study tests a high-precision radiation treatment called SABR in two sessions over one week. It aims to deliver 26 Gy to the prostate and up to 32 Gy to the dominant intraprostatic lesion using MRI guidance to improve quality of life outcomes.See study design
What are the potential side effects?
Potential side effects of SABR may include urinary issues like frequency and discomfort; bowel changes such as diarrhea; fatigue; skin reactions in treated areas; erectile dysfunction; and less commonly rectal bleeding.
2SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis has been confirmed by a lab test.
Select...
I am a man aged 18 or older.
2SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
QOL
Secondary outcome measures
Acute Toxicity
Biochemical Recurrance
Health Utilities
+3 more2SMART Trial Design
1Treatment groups
Experimental Treatment
Group I: 2-fraction SABRExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SABR
2013
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
657 Previous Clinical Trials
1,551,152 Total Patients Enrolled
34 Trials studying Prostate Cancer
12,608 Patients Enrolled for Prostate Cancer
Andrew Loblaw, MD, FRCPCPrincipal InvestigatorSunnybrook Health Sciences Centre, University of Toronto
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer diagnosis has been confirmed by a lab test.I have a bleeding disorder.I am a man aged 18 or older.I am not taking any immunosuppressive medications.My prostate cancer is at an early stage, with low Gleason score and PSA levels.I cannot safely stop my blood thinner for a procedure.I have inflammatory bowel disease.I have been on hormone therapy for my cancer for over 6 months.I have had radiation therapy to my pelvic area before.My prostate is larger than 90cm3 according to scans.
Research Study Groups:
This trial has the following groups:- Group 1: 2-fraction SABR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting participants for this investigation?
"The information found on clinicaltrials.gov confirms that this medical study, posted April 23rd 2018 and last edited June 12th 2022 is not accepting patient applications at present. However, an impressive 1321 other trials are presently recruiting participants across the globe."
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