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Brachytherapy
HDR Brachytherapy for Prostate Cancer
N/A
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No TRUP within the past 6 months, nor large TURP defect
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 yrs
Awards & highlights
Study Summary
This trial will investigate a new, more targeted form of radiation therapy for prostate cancer, which may result in fewer side effects and improved quality of life.
Who is the study for?
Men over 18 with early-stage, low to favorable intermediate-risk prostate cancer can join this study. They should be in good health (ECOG status 0-2), have a prostate size <80cc, and no history of severe rectal conditions or certain autoimmune diseases. No prior radiation or brachytherapy for the prostate is allowed, and they must not have any contraindications to MRI or anesthesia.Check my eligibility
What is being tested?
The trial is testing two types of high dose rate (HDR) brachytherapy treatments for localized prostate cancer: one that targets the whole gland and another that focuses on specific areas identified by MRI. The goal is to see if focal treatment reduces side effects while maintaining effectiveness.See study design
What are the potential side effects?
Potential side effects include urinary discomfort, incontinence, rectal symptoms like bleeding or pain, and sexual dysfunction such as erectile problems. These are common with traditional whole-gland treatments; the trial will assess if focal therapy lessens these issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had a prostate surgery or a large prostate tissue removal in the last 6 months.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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My prostate cancer is confirmed by tissue analysis.
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My prostate is smaller than 80cc.
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I can safely undergo general or spinal/epidural anesthesia.
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I don't have bleeding disorders and can stop blood thinners for brachytherapy.
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I have never had Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or Lupus.
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I don't have severe hemorrhoids, recent colorectal surgery, or a missing rectum.
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I have not had radiation therapy to my pelvis or prostate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 yrs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 yrs
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients achieving biochemical control
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tumour visible on MRIExperimental Treatment1 Intervention
Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose
Group II: No tumour visible on MRIActive Control1 Intervention
Whole-gland HDR Brachytherapy
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,474 Previous Clinical Trials
485,012 Total Patients Enrolled
63 Trials studying Prostate Cancer
15,370 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am able to care for myself and perform daily activities.My prostate cancer is confirmed by tissue analysis.My prostate is smaller than 80cc.My scans show no signs of cancer spread.I can safely undergo general or spinal/epidural anesthesia.I don't have bleeding disorders and can stop blood thinners for brachytherapy.I have never had Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or Lupus.My doctor agrees I am fit for prostate HDR brachytherapy.I haven't had a prostate surgery or a large prostate tissue removal in the last 6 months.My prostate cancer is classified as low or favorable intermediate-risk.I don't have severe hemorrhoids, recent colorectal surgery, or a missing rectum.I have not had radiation therapy to my pelvis or prostate.
Research Study Groups:
This trial has the following groups:- Group 1: No tumour visible on MRI
- Group 2: Tumour visible on MRI
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.
How many individuals have signed up for participation in this clinical trial thus far?
"Indeed, the current information on clinicaltrials.gov points to this trial being actively recruiting patients. This study was initially published in October 2016 and last modified in 2020 - with a goal of 30 participants at 1 site."
Answered by AI
Are there any vacancies still available for individuals to take part in this research?
"According to clinicaltrials.gov, this research project is actively recruiting participants as of October 20th 2022 - after it was initially opened for enrollment on 14th October 2016."
Answered by AI
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