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Brachytherapy
MRI-Guided Radiation Therapy for Prostate Cancer (MARS Trial)
N/A
Waitlist Available
Led By Andrew Loblaw, 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
Histologically confirmed diagnosis of adenocarcinoma of the prostate
Low and Intermediate risk disease defined as T1-T2c, Gleason < 7 and PSA < 20 ng/ml
Must not have
Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Previous pelvic radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a higher dose of radiation to the area of the prostate where the cancer is located is safe and effective.
Who is the study for?
This trial is for men with low to intermediate risk prostate cancer, characterized by specific clinical features (T1-T2c, Gleason score <7, PSA <20 ng/ml), a prostate size less than 60 cc, and no distant metastases. Participants must be able to undergo MRI scans and have not had certain previous treatments or conditions that would exclude them from MR imaging or radiotherapy.
What is being tested?
The study is testing the safety and effectiveness of using high dose rate brachytherapy with an MRI-assisted focal boost on the whole gland in treating prostate cancer. The goal is to see if targeting higher radiation doses directly at the primary disease area can improve outcomes without increasing harm to surrounding tissues.
What are the potential side effects?
Potential side effects may include urinary issues due to inflammation or damage from radiation, bowel complications like diarrhea or discomfort, erectile dysfunction as a result of nerve damage near the treatment area, and general fatigue commonly associated with radiation therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer diagnosis was confirmed through a tissue examination.
Select...
My prostate cancer is in the early or intermediate stage.
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My prostate is smaller than 60 cc according to imaging tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a health condition that makes general anesthesia risky for me.
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I have had radiation therapy to my pelvic area before.
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I have had surgery or HIFU treatment for prostate issues before.
Select...
I cannot undergo prostate radiotherapy due to certain health conditions like connective tissue or inflammatory bowel disease.
Select...
My cancer has spread to lymph nodes or other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acute GU and GI toxicities
Secondary study objectives
Changes in urinary symptoms
Late GU and GI toxicities
Quality of life changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MRI assisted HDR monotherapyExperimental Treatment1 Intervention
HDR monotherapy to the whole prostate gland (19Gy/1) with MRI assisted focal boost to intraprostatic nodule up to 22.5Gy
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Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,825 Total Patients Enrolled
31 Trials studying Prostate Cancer
12,021 Patients Enrolled for Prostate Cancer
Andrew Loblaw, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
7 Previous Clinical Trials
480 Total Patients Enrolled
6 Trials studying Prostate Cancer
328 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that makes general anesthesia risky for me.I have had radiation therapy to my pelvic area before.My prostate cancer diagnosis was confirmed through a tissue examination.My prostate cancer is in the early or intermediate stage.My prostate is smaller than 60 cc according to imaging tests.I have had surgery or HIFU treatment for prostate issues before.I cannot undergo prostate radiotherapy due to certain health conditions like connective tissue or inflammatory bowel disease.My cancer has spread to lymph nodes or other parts of my body.I am currently on hormone therapy for my condition.
Research Study Groups:
This trial has the following groups:- Group 1: MRI assisted HDR monotherapy
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.
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