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Brachytherapy
High vs Low Dose Rate Brachytherapy for Prostate Cancer
N/A
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Study Summary
This trial is testing two different types of radiation therapy to see which is better at treating prostate cancer.
Who is the study for?
Men over 18 with recently diagnosed low or intermediate risk prostate cancer, who haven't had hormone therapy, surgery, radiation, or chemotherapy for it. They should be fit for brachytherapy, have a prostate size ≤60 cc and an AUA score ≤20. Participants must complete questionnaires in English/French and agree to prevent pregnancy during the trial.Check my eligibility
What is being tested?
The study compares two types of radiation treatments: High Dose Rate (HDR) brachytherapy with a new higher dose against Low Dose Rate (seed) brachytherapy. It aims to see which is better at controlling cancer and assesses short/long-term side effects.See study design
What are the potential side effects?
Possible side effects include discomfort or pain from the procedure, urinary issues like frequency or urgency, bowel changes such as diarrhea, erectile dysfunction, and rare risks associated with anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brachytherapy
Secondary outcome measures
Disease
Economic Analysis
Number and severity of adverse events
+1 moreOther outcome measures
Malignant Neoplasms
Establish a comprehensive tumour bank linked to a clinical database for further studies of predictive and prognostic biomarkers in prostate cancer
Biopsy
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Arm 3 HDRActive Control1 Intervention
High Dose Rate brachytherapy: 27 Gy in 2 fractions
Group II: Arm 1 LDRActive Control1 Intervention
Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,221 Total Patients Enrolled
10 Trials studying Prostate Cancer
6,903 Patients Enrolled for Prostate Cancer
Eric VigneaultStudy ChairHotel Dieu de Quebec, Montreal, QC
1 Previous Clinical Trials
57 Total Patients Enrolled
1 Trials studying Prostate Cancer
57 Patients Enrolled for Prostate Cancer
Gerard MortonStudy ChairSunnybrook Health Sciences, Toronto ON
1 Previous Clinical Trials
55 Total Patients Enrolled
1 Trials studying Prostate Cancer
55 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken alpha-reductase inhibitors in the last 90 days.I do not have any serious health issues that would stop me from following the study's requirements.I am being actively monitored for my condition, it's getting worse, and I had a prostate biopsy in the last 9 months.I have a history of unusual bleeding or clotting.I have undergone hormone therapy for cancer.I have had major surgery, radiation, chemotherapy, TURP, or cryosurgery for prostate cancer.My cancer has spread to other parts of my body.My prostate cancer was confirmed by a biopsy within the last 9 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3 HDR
- Group 2: Arm 1 LDR
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.
In how many venues is this research project being conducted?
"Presently, the study is enrolling participants from 6 locations: Ottawa, Toronto and Montreal among them. To reduce travel costs for those who choose to participate, it is advisable to select a research centre nearby."
Answered by AI
Are there any openings for enrollment in this clinical experiment right now?
"Affirmative. According to the information available on clinicaltrials.gov, this scientific research is actively recruiting participants. Initially posted on November 4th 2016 and last updated September 12th 2022, it seeks 232 individuals from 6 sites for participation."
Answered by AI
What is the cap on enrolment for this clinical research?
"Indeed, the information hosted on clinicaltrials.gov attests to this trial's recruitment status; it was initially submitted on November 4th 2016 and then updated September 12th 2022. 232 participants need to be recruited from 6 different healthcare facilities."
Answered by AI
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